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510(k) K791383

CANDIDA IMMUNODIFFUSION KIT #CA1001 by Immuno-Mycologics, Inc. — Product Code GMI

K791383 is an FDA 510(k) premarket notification submitted by Immuno-Mycologics, Inc. for the device "CANDIDA IMMUNODIFFUSION KIT #CA1001". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code GMI (Antigen, Cf And / Or Id, Coccidioides Immitis), a Class II device regulated under 21 CFR 866.3135. 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
Antigen, Cf And / Or Id, Coccidioides Immitis
Device Class
Class II
Regulation Number
866.3135
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 GMI

  • K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (October 31, 1989)
  • K812190 — COCCIDIOIDES IMMUNODIFFUSION SYSTEM (August 31, 1981)
  • K812185 — FUNGAL IMMUNODIFFUSION SYSTEM (August 25, 1981)
  • K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL (September 26, 1980)
  • K792716 — CANDIDA ALBICANS, ANTIGEN (January 24, 1980)
  • K792713 — CANDIDA ALBICANS, ANTISERUM (January 23, 1980)
  • K792682 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K792689 — COCCIDIOIDES IMMITIS, ANTIGEN (January 17, 1980)
  • K791389 — COCCIDIOIDES ANTIGEN #CF10023X (August 16, 1979)
  • K770527 — CANDIDA IMMUNODIFFUSION KIT (March 17, 1978)

FDA data resources