FDA 510(k) Applications Submitted by STANBIO LABORATORY

FDA 510(k) Number Submission Date Device Name Applicant
K810055 01/13/1981 STANBIO BILIRUBIN TEST SET STANBIO LABORATORY
K780110 01/19/1978 CSF TOTAL PROTEIN TEST SET #0340 STANBIO LABORATORY
K800190 01/29/1980 STANBIO DIRECT URIC ACID TEST SET #0770 STANBIO LABORATORY
K800693 03/27/1980 STANBIO PROSTATIC ACID PHOSPHATASE TEST STANBIO LABORATORY
K780545 04/03/1978 SR-PLUS DIRECT CHOLESTEROL TEST STANBIO LABORATORY
K801014 04/28/1980 STANBIO ACETAMINOPHEN TEST SET #0850 STANBIO LABORATORY
K831858 06/10/1983 TRIGLYCERIDES REAGENT SET STANBIO LABORATORY
K831863 06/10/1983 CHOLESTEROL-ENZYMATIC REAGENT SET STANBIO LABORATORY
K831864 06/10/1983 URIC-ACID TEST ENZYMATIC COLORIMETRIC STANBIO LABORATORY
K842544 07/02/1984 STANBIO QUICK-TELL MONOCLONAL INDIRECT STANBIO LABORATORY
K832159 07/05/1983 UNITIZED ENZYMATIC GLUCOSE TEST SET STANBIO LABORATORY
K832444 07/25/1983 ENZYMATIC TRIGLYCERIDES #2000 STANBIO LABORATORY
K832557 08/01/1983 FERTITELL DIRECT PREGNANCY TEST #1100 STANBIO LABORATORY
K832640 08/04/1983 QUICK-TELL INDIRECT PREGNANCY TEST STANBIO LABORATORY
K832867 08/24/1983 FERTITUBE PREGNANCY TEST #1120 STANBIO LABORATORY
K771771 09/19/1977 QUAN. COLOR. DETER. OF SERUM ALBUMIN STANBIO LABORATORY
K781635 09/22/1978 CHLORIDE TEST SET, CAT.# 0210 STANBIO LABORATORY
K771856 09/29/1977 DIR. QUANT. COLOR. DETERM. SERUM CREAT. STANBIO LABORATORY
K823237 11/01/1982 BARBITURATE TEST SET #0550-050 STANBIO LABORATORY
K781865 11/06/1978 IRON BINDING CAPICITY MODEL 0370 STANBIO LABORATORY
K813349 11/27/1981 BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL STANBIO LABORATORY
K772257 12/05/1977 ALKALINE PHOSPHATASE TEST SET STANBIO LABORATORY
K041155 05/03/2004 WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY STANBIO LABORATORY
K032932 09/22/2003 DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR STANBIO LABORATORY
K032936 09/22/2003 DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR STANBIO LABORATORY
K941313 03/18/1994 STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET STANBIO LABORATORY
K941314 03/18/1994 STANBIO ALT/GPT (LUQUI-UV) TEST SET STANBIO LABORATORY
K941315 03/18/1994 STANBIO Y-GT (LIQUICOLOR) TEST SET STANBIO LABORATORY
K851278 04/01/1985 ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870 STANBIO LABORATORY
K932049 04/27/1993 STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020 STANBIO LABORATORY
K902204 05/16/1990 STANBIO CSF/URINE TOTAL PROTEIN TEST SET STANBIO LABORATORY
K090093 01/14/2009 STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM STANBIO LABORATORY
K050266 02/04/2005 DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR STANBIO LABORATORY
K020378 02/05/2002 QUPID PLUS E.R. STANBIO LABORATORY
K050283 02/07/2005 CREATININE LIQUICOLOR STANBIO LABORATORY
K972155 06/05/1997 CREATINE KINASE (CK) STANBIO LABORATORY
K081719 06/18/2008 STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM STANBIO LABORATORY
K962418 06/24/1996 UREA NITROGEN (BUN) LIQUI-UV STANBIO LABORATORY
K042169 08/11/2004 STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER STANBIO LABORATORY
K032482 08/12/2003 STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM STANBIO LABORATORY
K974370 11/20/1997 RAPET RF STANBIO LABORATORY
K974429 11/24/1997 RAPET CRP STANBIO LABORATORY
K870746 02/25/1987 STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 STANBIO LABORATORY
K883170 07/27/1988 STANBIO MAGNESIUM TEST SET, CAT. NO 0130 STANBIO LABORATORY
K880144 01/13/1988 STANBIO SYPHILIS RPR TEST, NO. 1170 STANBIO LABORATORY
K880467 02/03/1988 STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR STANBIO LABORATORY
K893128 04/25/1989 STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 STANBIO LABORATORY


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