FDA 510(k) Applications Submitted by HARLECO

FDA 510(k) Number Submission Date Device Name Applicant
K780065 01/12/1978 ULTRACHEM E-GLU, MANUAL DETERM. HARLECO
K780092 01/18/1978 ULTRACHEM ALBUMIN HARLECO
K780093 01/18/1978 GLUCOSE REAGENT FOR GLUCOSE ANALYZER HARLECO
K780094 01/18/1978 IRON BINDING CAPACITY CHEMISTRY HARLECO
K780095 01/18/1978 ULTRAZYME PLUS ALP HARLECO
K780099 01/20/1978 ULTRAZYME PLUS GT HARLECO
K780100 01/20/1978 ULTRAZYME PLUS CK-1 HARLECO
K780101 01/20/1978 ULTRAZYME PLUS LDH HARLECO
K780102 01/20/1978 ULTRAZYME PLUS GPT HARLECO
K780103 01/20/1978 ULTRAZYME PLUS GOT HARLECO
K780104 01/20/1978 ULTRAZYME PLUS HBD HARLECO
K770121 01/21/1977 MANUEL BILIRUBIN REAGENT SET HARLECO
K780141 01/26/1978 ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI. HARLECO
K820233 01/28/1982 ULTRAZYME PLUS GAMMA GT(65055-65056) HARLECO
K780172 02/02/1978 TRIGLYCERIDE INSTRUMENT APPLICATION HARLECO
K770229 02/07/1977 AUTO-ENZYMATIC GLUCOSE HARLECO
K810684 03/13/1981 HEMOCOLOR STAIN SET HARLECO
K810725 03/17/1981 QUALITROL #65057 HARLECO
K780513 03/30/1978 ULTRA ZYME PLUS AMYL 64982, GILFORD 3500 HARLECO
K780514 03/30/1978 ULTRACHEM CREATININE 64972, CENTRIFUCHEM HARLECO
K780515 03/30/1978 ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM HARLECO
K780523 03/31/1978 ULTRACHEM ENZYMATIC CHOLESTEROL 65025 HARLECO
K780524 03/31/1978 ULTRACHEM T-BILI 64971 GILFORD 3500 HARLECO
K811202 05/01/1981 ULTRACHEM GLUC-DH, ITEM NO. 65048 HARLECO
K770815 05/04/1977 ULTRAZYME PLUS GT HARLECO
K770816 05/04/1977 ULTRACHEM ALBUMIN HARLECO
K770817 05/04/1977 ULTRACHEM CALCIUM HARLECO
K770818 05/04/1977 ULTRAZYME PLUS, LDH HARLECO
K770819 05/04/1977 ULTRACHEM CREATININE HARLECO
K770820 05/04/1977 ULTRACHEM INORGANIC PHOSPHORUS HARLECO
K770870 05/13/1977 ULTRAZYME PLUS ALP HARLECO
K770871 05/13/1977 ULTRAZYME PLUS HBD HARLECO
K770887 05/16/1977 AUTO TOTAL PROTEIN FOR ANALYZER HARLECO
K770882 05/16/1977 ULTRAZYME PLUS GPT HARLECO
K770883 05/16/1977 ULTRAZYME PLUS GOT HARLECO
K770886 05/16/1977 AUTO-ENZYMATIC GLUCOSE FOR ANALYZER HARLECO
K780829 05/19/1978 SYSING AND HEMOGLOBIN REAGENT HARLECO
K780830 05/19/1978 ISOTONIC BUFFERED SALINE HARLECO
K811573 06/04/1981 CARDIOZYME PLUS CK-MB ITEM #65045 HARLECO
K811574 06/04/1981 CARDIOZYME PLUS CK-TOTAL ITEM #65046 HARLECO
K811575 06/04/1981 CARDIOZYME PLUS CK-MB ITEM #65045 (G) HARLECO
K811576 06/04/1981 CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A) HARLECO
K760023 06/14/1976 ULTRAZYME HBD HARLECO
K760024 06/14/1976 ULTRAZYME ALKALINE PHOSPHATASE HARLECO
K760025 06/14/1976 ULTRAZYME GT HARLECO
K760026 06/14/1976 ULTRAZYME AMYLASE HARLECO
K760027 06/14/1976 DSP - STAIN PACK HARLECO
K760028 06/14/1976 CPK - ISOENZYMES HARLECO
K760029 06/14/1976 ENZYMATIC TRIGLYCERIDE HARLECO
K760030 06/14/1976 CLINICARD PHOSPHORUS HARLECO
K760031 06/14/1976 HISTOCHEMICAL PAS REACTION SET HARLECO
K771087 06/16/1977 UNIPAK BUN HARLECO
K771088 06/16/1977 UNIPAK URIC ACID HARLECO
K771089 06/16/1977 UNIPAK TOTAL BILIRUBIN HARLECO
K771090 06/16/1977 UNIPAK HEMOGLOBIN HARLECO
K771091 06/16/1977 UNIPAK GLUCOSE HARLECO
K771092 06/16/1977 UNIPAK TOTAL & DIRECT BILIRUBIN HARLECO
K771093 06/16/1977 UNIPAK CHOLESTEROL HARLECO
K771094 06/16/1977 UNIPAK ALBUMIN HARLECO
K771131 06/23/1977 CLINICARD UV AMYLASE CHEMISTRY HARLECO
K760129 06/28/1976 SALINE, ISOTONIC BUFFERED, AZIDE-FREE HARLECO
K771388 07/27/1977 AMYLASE ULTRAZYME PLUS HARLECO
K771389 07/27/1977 CK-1 ULTRAZYME PLUS HARLECO
K771390 07/27/1977 HISTOCHEMICAL AFB DEMONSTRATION HARLECO
K771524 08/08/1977 HISTOCHEMICAL FERRIC IRON SET HARLECO
K812258 08/12/1981 ACR ENZYMATIC GLUCOSE OXIDASE HARLECO
K760484 08/20/1976 STAIN SET, HISTOCHEMICAL AFB HARLECO
K812500 08/31/1981 ULTRACHEM URIC ACID ALDH, ITEM #65047 HARLECO
K812589 09/11/1981 ULTRA CHEM E-TRIG #65024 HARLECO
K812590 09/11/1981 ULTRA ZYME PLUS LDH #64950, 65038 & 39 HARLECO
K812591 09/11/1981 ULTRA ZYME PLUS GPT, #64956, 65035 & 36 HARLECO
K812592 09/11/1981 ULTRA ZYME PLUS GOT #64953, 65033 & 34 HARLECO
K812593 09/11/1981 ULTRA ZYME PLUS CK-1 #64978, 65027 & 28 HARLECO
K812594 09/11/1981 ULTRA ZYME PLUS AMYL #64982 & 65031 HARLECO
K812595 09/11/1981 ULTRA CHEM E-GLU #64976 & 65040 HARLECO
K812596 09/11/1981 ULTRA ZYME PLUS ALP #64962, 65029 & 30 HARLECO
K771754 09/16/1977 GLUCOSE REAGENT FOR GLUC. ANALYZER HARLECO
K771773 09/19/1977 CLINICARD CREATININE CHEMISTRY HARLECO
K771925 10/14/1977 KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP HARLECO
K771926 10/14/1977 TOTAL PROTEIN SET, ITEM NO. 64010 HARLECO
K771927 10/14/1977 IRON SET, ITEM NO. 65008 HARLECO
K771928 10/14/1977 CALCIUM SET, ITEM NO. 65004 HARLECO
K772028 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS LDH HARLECO
K772029 10/27/1977 GEMSAEC APPLI, FOR ULTRAZYME PLUS GOT HARLECO
K772030 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS GPT HARLECO
K772031 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-GT HARLECO
K772032 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP HARLECO
K772033 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP* HARLECO
K772034 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS CK-1 HARLECO
K772035 10/27/1977 GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL HARLECO
K813038 10/28/1981 ULTRACHEM TP, ITEM #64974 HARLECO
K813039 10/28/1981 ULTRACHEM E-CHOL, ITEM #65025 HARLECO
K813040 10/28/1981 ULTRACHEM CA, ITEM #64975 HARLECO
K813041 10/28/1981 ULTRAZYME-GT, ITEM #64959 & 65032 HARLECO
K813042 10/28/1981 ULTRACHEM GLUC-DH SET, ITEM #65048 HARLECO
K813043 10/28/1981 ULTRACHEM CREA ITEM #64972 HARLECO
K813044 10/28/1981 ULTRACHEM ALB, ITEM #64970 HARLECO
K772107 11/07/1977 CREATININE URINE APPLI.-#32308 HARLECO
K761029 11/12/1976 AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL HARLECO
K761027 11/12/1976 AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN HARLECO
K761028 11/12/1976 AUTO-ALBUMIN REAG FOR ABBOTT ABA-100 HARLECO
K772157 11/16/1977 CREATININE, 64972 HARLECO
K772155 11/16/1977 ULTRACHEM TOTAL PROTEIN, #64974 HARLECO
K772156 11/16/1977 ULTRACHEM PHOSPHORUS, 64973 HARLECO
K761217 12/07/1976 AUTO TOTAL PROTEIN HARLECO
K761218 12/07/1976 AUTO TOTAL BILIRUBIN REAGENT HARLECO
K761257 12/07/1976 AUTO TOTAL PROTEIN HARLECO
K813427 12/07/1981 ULTRACHEM GLUC-DH HARLECO
K772258 12/09/1977 CLINICARD CK-II HARLECO
K761238 12/13/1976 AUTO-INORGANIC PHOSPHORUS REAGENT HARLECO
K761239 12/13/1976 AUTO-INORGANIC PHOSPHORUS REAGENT HARLECO
K761240 12/13/1976 AUTO-ENZYMATIC GLUCOSE HARLECO
K803168 12/15/1980 CARDIO ZYME PLUS CK-MB #65045 HARLECO
K803169 12/15/1980 CARDIOZYME PLUS CK-TOTAL #65046 HARLECO
K761279 12/20/1976 AUTO CREATININE REAGENT (ABBOTT SYSTEM) HARLECO
K761280 12/20/1976 AUTO CREATININE REAGENT (GILFORD 3400-E) HARLECO


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