FDA 510(k) Applications Submitted by RAYMOND MILLER

FDA 510(k) Number Submission Date Device Name Applicant
K860134 01/14/1986 EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT EM DIAGNOSTIC SYSTEMS, INC.
K860135 01/14/1986 EASY-TEST UREA (BUN) REAGENT EM DIAGNOSTIC SYSTEMS, INC.
K980638 02/19/1998 ADI SYPHILIS RPR LIQUID CONTROLS AMPCOR DIAGNOSTICS, INC.
K862453 06/27/1986 EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93 EM DIAGNOSTIC SYSTEMS, INC.
K870143 01/13/1987 AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 EM DIAGNOSTIC SYSTEMS, INC.
K870144 01/13/1987 IRON(IRN) TESTPACK, ITEM NO. 67659/95 EM DIAGNOSTIC SYSTEMS, INC.
K850128 01/14/1985 SYSTE MATE TIBC HEM NO. 67225 EM DIAGNOSTIC SYSTEMS, INC.
K870170 01/14/1987 EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 EM DIAGNOSTIC SYSTEMS, INC.
K870247 01/21/1987 EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93 EM DIAGNOSTIC SYSTEMS, INC.
K880339 01/26/1988 EASY-TEST POTASSIUM K ITEM NUMBER 19XXX EM DIAGNOSTIC SYSTEMS, INC.
K910438 01/31/1991 DIPSTICK SALMONELLA AMPCOR, INC.
K870461 02/03/1987 EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 EM DIAGNOSTIC SYSTEMS, INC.
K870462 02/03/1987 EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 EM DIAGNOSTIC SYSTEMS, INC.
K870407 02/03/1987 EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 EM DIAGNOSTIC SYSTEMS, INC.
K870408 02/03/1987 EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 EM DIAGNOSTIC SYSTEMS, INC.
K870553 02/10/1987 EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX EM DIAGNOSTIC SYSTEMS, INC.
K870571 02/10/1987 EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 EM DIAGNOSTIC SYSTEMS, INC.
K860640 02/20/1986 EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93 EM DIAGNOSTIC SYSTEMS, INC.
K860641 02/20/1986 EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 EM DIAGNOSTIC SYSTEMS, INC.
K860668 02/24/1986 ION-SPECIFIC ELECTRODE, CHLORIDE EM DIAGNOSTIC SYSTEMS, INC.
K860669 02/24/1986 CREATINE KINASE, N-ACETYL-L-CYSTIENE EM DIAGNOSTIC SYSTEMS, INC.
K880787 02/26/1988 EASY-TEST LACTIC ACID (LA) DIAGNOSTIC SYSTEMS
K860764 03/03/1986 EMDS ENZYME VERIFIER, LEVELS I & II EM DIAGNOSTIC SYSTEMS, INC.
K860765 03/03/1986 EMDS CHEMISTRY CALIBRATORS, LEVELS I & II EM DIAGNOSTIC SYSTEMS, INC.
K870868 03/03/1987 EASY-TEST URIC ACID (URIC) #16606 EM DIAGNOSTIC SYSTEMS, INC.
K860916 03/11/1986 EASY-TEST URIC ACID (URIC), #67516/93 EM DIAGNOSTIC SYSTEMS, INC.
K860917 03/11/1986 EASY-TEST TOTAL PROTEIN (TP), #67513/93 EM DIAGNOSTIC SYSTEMS, INC.
K860935 03/12/1986 EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 EM DIAGNOSTIC SYSTEMS, INC.
K881116 03/15/1988 EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 DIAGNOSTIC SYSTEMS
K861055 03/19/1986 EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95 EM DIAGNOSTIC SYSTEMS, INC.
K861061 03/20/1986 EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK EM DIAGNOSTIC SYSTEMS, INC.
K881229 03/22/1988 AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 EM DIAGNOSTIC SYSTEMS, INC.
K881337 03/29/1988 EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95 EM DIAGNOSTIC SYSTEMS, INC.
K861221 04/01/1986 EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST EM DIAGNOSTIC SYSTEMS, INC.
K871329 04/03/1987 EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640 EM DIAGNOSTIC SYSTEMS, INC.
K871330 04/03/1987 EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 EM DIAGNOSTIC SYSTEMS, INC.
K871414 04/08/1987 EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 EM DIAGNOSTIC SYSTEMS, INC.
K881607 04/12/1988 EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 EM DIAGNOSTIC SYSTEMS, INC.
K861512 04/23/1986 EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 EM DIAGNOSTIC SYSTEMS, INC.
K871638 04/27/1987 EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 EM DIAGNOSTIC SYSTEMS, INC.
K852066 05/10/1985 PREGNANCY CARD TEST EM DIAGNOSTIC SYSTEMS, INC.
K872110 06/01/1987 EASY-TEST AMMONIA (AMON) ITEM NO. 16695 EM DIAGNOSTIC SYSTEMS, INC.
K852481 06/11/1985 UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM EM DIAGNOSTIC SYSTEMS, INC.
K852482 06/11/1985 MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 EM DIAGNOSTIC SYSTEMS, INC.
K852483 06/11/1985 SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 EM DIAGNOSTIC SYSTEMS, INC.
K862308 06/17/1986 EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93 EM DIAGNOSTIC SYSTEMS, INC.
K872320 06/17/1987 EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 EM DIAGNOSTIC SYSTEMS, INC.
K872321 06/17/1987 EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 EM DIAGNOSTIC SYSTEMS, INC.
K872322 06/17/1987 EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 EM DIAGNOSTIC SYSTEMS, INC.
K872330 06/17/1987 EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 EM DIAGNOSTIC SYSTEMS, INC.
K862349 06/20/1986 EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93 EM DIAGNOSTIC SYSTEMS, INC.
K862350 06/20/1986 EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 EM DIAGNOSTIC SYSTEMS, INC.
K872513 06/24/1987 EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 EM DIAGNOSTIC SYSTEMS, INC.
K872512 06/24/1987 EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 EM DIAGNOSTIC SYSTEMS, INC.
K862403 06/26/1986 EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 DIAGNOSTIC SYSTEMS
K862525 07/02/1986 EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95 EM DIAGNOSTIC SYSTEMS, INC.
K872653 07/07/1987 EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 EM DIAGNOSTIC SYSTEMS, INC.
K862703 07/15/1986 EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95 EM DIAGNOSTIC SYSTEMS, INC.
K862704 07/15/1986 EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 EM DIAGNOSTIC SYSTEMS, INC.
K862707 07/16/1986 EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 EM DIAGNOSTIC SYSTEMS, INC.
K862706 07/16/1986 EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95 EM DIAGNOSTIC SYSTEMS, INC.
K872813 07/16/1987 EASY ST ANALYZER SYSTEM EM DIAGNOSTIC SYSTEMS, INC.
K862845 07/29/1986 EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 EM DIAGNOSTIC SYSTEMS, INC.
K863002 08/08/1986 EMDS(TM) MAGNESIUM TESTPACKS, #67671/95 EM DIAGNOSTIC SYSTEMS, INC.
K863003 08/08/1986 EMDS(TM) CALCIUM TESTPACKS, #67687/95 EM DIAGNOSTIC SYSTEMS, INC.
K863004 08/08/1986 EMDS(TM) ALBUMIN TESTPACKS, #67652/95 EM DIAGNOSTIC SYSTEMS, INC.
K863005 08/08/1986 EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95 EM DIAGNOSTIC SYSTEMS, INC.
K863094 08/13/1986 SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) EM DIAGNOSTIC SYSTEMS, INC.
K873349 08/20/1987 EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 EM DIAGNOSTIC SYSTEMS, INC.
K873350 08/20/1987 EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 EM DIAGNOSTIC SYSTEMS, INC.
K853532 08/23/1985 ALCOHOL CALIBRATORS DIAGNOSTIC SYSTEMS
K853533 08/23/1985 ABSORBANCE TEST SOLUTION DIAGNOSTIC SYSTEMS
K873424 08/25/1987 EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 EM DIAGNOSTIC SYSTEMS, INC.
K873425 08/25/1987 EASY-TEST SALICYLATE (SAL) #16691 EM DIAGNOSTIC SYSTEMS, INC.
K873426 08/25/1987 EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 EM DIAGNOSTIC SYSTEMS, INC.
K873436 08/27/1987 EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95 EM DIAGNOSTIC SYSTEMS, INC.
K873551 08/31/1987 CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95 EM DIAGNOSTIC SYSTEMS, INC.
K863419 09/03/1986 EMDS(TM) ALCOHOL TESTPACKS, #67691/95 EM DIAGNOSTIC SYSTEMS, INC.
K853699 09/04/1985 EASY ANALYZER & EASY-TEST REAGENT DIAGNOSTIC SYSTEMS
K863477 09/09/1986 EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 EM DIAGNOSTIC SYSTEMS, INC.
K863478 09/09/1986 CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 EM DIAGNOSTIC SYSTEMS, INC.
K873635 09/09/1987 EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 EM DIAGNOSTIC SYSTEMS, INC.
K863544 09/12/1986 EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95 EM DIAGNOSTIC SYSTEMS, INC.
K863545 09/12/1986 EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 EM DIAGNOSTIC SYSTEMS, INC.
K873681 09/14/1987 ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95 EM DIAGNOSTIC SYSTEMS, INC.
K863660 09/18/1986 EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 EM DIAGNOSTIC SYSTEMS, INC.
K863718 09/23/1986 EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95 EM DIAGNOSTIC SYSTEMS, INC.
K863738 09/23/1986 EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 EM DIAGNOSTIC SYSTEMS, INC.
K873994 10/01/1987 EASY-TEST ALBUMIN (ALB), ITEM NO. 19039 EM DIAGNOSTIC SYSTEMS, INC.
K874088 10/07/1987 EASY-TEST CREATININE (CREA) ITEM NO. 19009 EM DIAGNOSTIC SYSTEMS, INC.
K874102 10/08/1987 EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95 EM DIAGNOSTIC SYSTEMS, INC.
K874101 10/08/1987 EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95 EM DIAGNOSTIC SYSTEMS, INC.
K863962 10/10/1986 EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95 EM DIAGNOSTIC SYSTEMS, INC.
K863963 10/10/1986 EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 EM DIAGNOSTIC SYSTEMS, INC.
K874153 10/13/1987 EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687 EM DIAGNOSTIC SYSTEMS, INC.
K864041 10/16/1986 EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 EM DIAGNOSTIC SYSTEMS, INC.
K874397 10/28/1987 EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683 EM DIAGNOSTIC SYSTEMS, INC.
K874476 11/02/1987 EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 EM DIAGNOSTIC SYSTEMS, INC.
K874477 11/02/1987 EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010 EM DIAGNOSTIC SYSTEMS, INC.
K874586 11/09/1987 EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 EM DIAGNOSTIC SYSTEMS, INC.
K874600 11/09/1987 EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 EM DIAGNOSTIC SYSTEMS, INC.
K854585 11/18/1985 ULTRAZYME PLUS & SYSTEMATE LDH EM DIAGNOSTIC SYSTEMS, INC.
K864553 11/19/1986 EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 EM DIAGNOSTIC SYSTEMS, INC.
K864554 11/19/1986 EASY-TEST PRIMIDONE ITEM NO. 67---/95 EM DIAGNOSTIC SYSTEMS, INC.
K874705 11/19/1987 EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 EM DIAGNOSTIC SYSTEMS, INC.
K874708 11/19/1987 EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008 EM DIAGNOSTIC SYSTEMS, INC.
K864607 11/24/1986 EASY-TEST QUINIDINE ITEM NO. 67---/95 EM DIAGNOSTIC SYSTEMS, INC.
K854784 11/29/1985 ABSORBANCE (ABS) TEST PAK DIAGNOSTIC SYSTEMS
K864715 12/03/1986 EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93 EM DIAGNOSTIC SYSTEMS, INC.
K875062 12/09/1987 EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 EM DIAGNOSTIC SYSTEMS, INC.
K864894 12/15/1986 EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 EM DIAGNOSTIC SYSTEMS, INC.
K864925 12/16/1986 EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95 EM DIAGNOSTIC SYSTEMS, INC.
K864926 12/16/1986 EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 EM DIAGNOSTIC SYSTEMS, INC.
K855056 12/18/1985 EMDS TOTAL CK TEST PACK-#67670/95 EM DIAGNOSTIC SYSTEMS, INC.
K855079 12/19/1985 NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 EM DIAGNOSTIC SYSTEMS, INC.
K855080 12/19/1985 EMDS GLUCOSE TEST PACK ITEM 67656/95 EM DIAGNOSTIC SYSTEMS, INC.
K845020 12/27/1984 SYSTE MATE IRON, HEM NO. 67224 EM DIAGNOSTIC SYSTEMS, INC.


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