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510(k) K791384

FUNGAL IMMUNODIFFUSION KIT #ID1001 by Immuno-Mycologics, Inc. — Product Code GMJ

K791384 is an FDA 510(k) premarket notification submitted by Immuno-Mycologics, Inc. for the device "FUNGAL IMMUNODIFFUSION KIT #ID1001". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code GMJ (Antigens, Histoplasma Capsulatum, All), a Class II device regulated under 21 CFR 866.3320. Immuno-Mycologics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1979
Date Received
July 11, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Histoplasma Capsulatum, All
Device Class
Class II
Regulation Number
866.3320
Review Panel
MI
Submission Type

Other clearances by Immuno-Mycologics, Inc.

  • K120946 — ALPHA CRYPTOCOCCAL ANTIGEN EIA (December 17, 2012)
  • K112422 — CRAG LATERAL FLOW ASSAY (LFA) (March 28, 2012)
  • K102286 — CRAG LATERAL FLOW ASSAY (CRAG LFA) (July 20, 2011)
  • K101407 — ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 (July 19, 2011)
  • K883333 — RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT (August 25, 1988)
  • K880029 — EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 (February 24, 1988)
  • K843286 — EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (October 1, 1984)
  • K831918 — LA-STAPH IDENTIFICATION SYSTEM (June 8, 1983)
  • K830837 — LA-HISTO ANTIBODY SYSTEM #HL 1001 (May 5, 1983)
  • K810510 — YA-CRYPTO ANTIBODY TUBE AGGLUTINATION (March 20, 1981)

Other clearances for product code GMJ

  • K830837 — LA-HISTO ANTIBODY SYSTEM #HL 1001 (May 5, 1983)
  • K813359 — MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL (December 31, 1981)
  • K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUM (September 26, 1980)
  • K792701 — HISTOPLASMA CAPSULATUM, ANTIGEN (January 23, 1980)
  • K792708 — HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (January 17, 1980)
  • K792711 — HISTOPLASMA CAPSULATUM, ANTISERUM (January 17, 1980)
  • K792704 — HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (January 17, 1980)
  • K791393 — HISTOPLASMA YEAST ANTI #CF10021X (August 16, 1979)
  • K791394 — HISTOPLASMA MYCELIAL #CF10020X (August 16, 1979)
  • K760827 — HISTOPLASMA YEAST ANTIGEN (November 1, 1976)

FDA data resources