Immuno-Mycologics, Inc.

FDA 510(k) & PMA Approved Devices — 26 products

Total Devices26

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K120946	ALPHA CRYPTOCOCCAL ANTIGEN EIA	MDU	2012-12-17	View
510(k)	K112422	CRAG LATERAL FLOW ASSAY (LFA)	GMD	2012-03-28	View
510(k)	K102286	CRAG LATERAL FLOW ASSAY (CRAG LFA)	GMD	2011-07-20	View
510(k)	K101407	ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102	MIZ	2011-07-19	View
510(k)	K883333	RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT	JTL	1988-08-25	View
510(k)	K880029	EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001	KFH	1988-02-24	View
510(k)	K843286	EI-CANDIDA ENZYME IMMUNOASSAY EI1001	LRF	1984-10-01	View
510(k)	K831918	LA-STAPH IDENTIFICATION SYSTEM	JWX	1983-06-08	View
510(k)	K830837	LA-HISTO ANTIBODY SYSTEM #HL 1001	GMJ	1983-05-05	View
510(k)	K810510	YA-CRYPTO ANTIBODY TUBE AGGLUTINATION	GMD	1981-03-20	View
510(k)	K802427	LA-SPORO ANTIBODY SYSTEM	GMA	1980-10-31	View
510(k)	K800908	CAPIK-CANDIDA ALBICANS IDENT. KIT.	JXB	1980-06-02	View
510(k)	K791394	HISTOPLASMA MYCELIAL #CF10020X	GMJ	1979-08-16	View
510(k)	K791382	CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION	GMD	1979-08-16	View
510(k)	K791385	NEGATIVE CONTROL SERUM FOR CF RO ID	GSN	1979-08-16	View
510(k)	K791389	COCCIDIOIDES ANTIGEN #CF10023X	GMI	1979-08-16	View
510(k)	K791392	ANTI-HISTOPLASMA SERUM #CF10026X	GMK	1979-08-16	View
510(k)	K791395	ANTI-HISTOPLASMA SERUM #CF10025X	GMK	1979-08-16	View
510(k)	K791388	ANTI-COCCIDIOIDES SERUM #CF10028X	GMH	1979-08-16	View
510(k)	K791384	FUNGAL IMMUNODIFFUSION KIT #ID1001	GMJ	1979-08-16	View