Gamma Biologicals, Inc.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K864207	DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO	KTN	1986-12-03	View
510(k)	K861016	GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS	KTN	1986-04-18	View
510(k)	K832473	GAMMA SLIDE TEST FOR PREGNANCY	JHJ	1983-08-16	View
510(k)	K820647	GAMMA FETAL BLEED SCREENING TEST	LIM	1982-05-12	View
510(k)	K820072	FE-CULT PLUS	KHE	1982-03-04	View
510(k)	K813342	GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION	KSK	1982-03-04	View
510(k)	K811752	FE-CULT PLUS	KHE	1981-11-02	View
510(k)	K802533	GAMMA LEWIS BLOOD GROUP SUBSTANCE	KSX	1980-11-12	View
510(k)	K802534	GAMMA PI BLOOD GROUP SUBSTANCE	KSX	1980-11-12	View
510(k)	K800658	RST-SERIES CONTROL	KSF	1980-04-16	View
510(k)	K792582	POLY-LEC SYSTEM	KSI	1980-01-16	View
510(k)	K792583	GAMMA ARACHIS HYPOGEA LECTIN	KSI	1980-01-16	View
510(k)	K790973	LO-ION	KSG	1979-06-15	View
510(k)	K760034	TEST, STREP, LATEX SLIDE	DEM	1976-08-11	View
510(k)	K760036	TEST, LATEX SLIDE, RHEUMATOID FACTOR	DHR	1976-08-03	View
510(k)	K760098	REAGENT, VDRL	GMT	1976-08-03	View
510(k)	K760096	REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O	GTQ	1976-08-03	View
510(k)	K760035	TEST, C-REATIVE PROTEIN, LATEX SLIDE	DCK	1976-08-03	View
510(k)	K760097	FEBRILE ANTIGENS & CONTROL SERUMS	GSZ	1976-08-03	View
510(k)	K760032	TEST, MONO., DIFFERENTIAL SLIDE	KIN	1976-08-03	View