General Diagnostics

FDA 510(k) & PMA Approved Devices — 39 products

Total Devices39

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K882663	BARBITURATE ENZYME IMMUNOASSAY KIT	DIS	1988-09-19	View
510(k)	K872882	CANNABINOID ENZYME IMMUNOASSAY KIT	LDJ	1987-11-03	View
510(k)	K871305	COCAINE METABOLITE ENZYME IMMUNOASSAY KIT	DIO	1987-06-05	View
510(k)	K864993	QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE	DIS	1987-03-31	View
510(k)	K863877	BENZODIAZEPINE ENZYME IMMUNOASSAY KIT	JXM	1987-03-12	View
510(k)	K842307	GENERAL DIAG. CEFONICID 30MCG ANTIMIC	JTN	1984-07-20	View
510(k)	K841465	GENERAL DIAGNOSTICS PLATELET ANTIBODY	LLG	1984-07-02	View
510(k)	K833709	CEFTIZOXIME 30 MCG ANTIMICROBIAL DISK	JTN	1983-12-30	View
510(k)	K832653	CEFUROXIME 30MCG. SUSCEP DISK	JTN	1983-10-14	View
510(k)	K831179	CEFAZOLIN 30MCG. ANTIMICROBIAL SUSCEP	JTN	1983-05-09	View
510(k)	K830731	NETILMICIN 30 MCG ANTIMICROBIAL DISK	JTN	1983-04-08	View
510(k)	K823453	VON WILLEBRAND FACTOR ASSAY	GGP	1983-01-21	View
510(k)	K823794	CONTROL TM 8	GLQ	1983-01-14	View
510(k)	K822809	AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC	JTN	1982-11-22	View
510(k)	K821229	CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK	JTN	1982-06-22	View
510(k)	K820468	PROFILE GENERAL SET ASSAYED SERUM CONTR	DIF	1982-03-25	View
510(k)	K820019	PIPERACILLIN 100MCG. ANTIMICROBIAL	JTN	1982-01-29	View
510(k)	K813564	COAG-A-MATE X2	GKP	1982-01-28	View
510(k)	K812994	MINOCYCLINE 30MCG ANTIMICROBIAL SUS. DSK	JTN	1981-12-17	View
510(k)	K812993	MOXALACTOM 30MCG ANTIMICROBIAL SUS. DISK	JTN	1981-11-10	View