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510(k) K112422

CRAG LATERAL FLOW ASSAY (LFA) by Immuno-Mycologics, Inc. — Product Code GMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2012
Date Received
August 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Latex Agglutination, Cryptococcus Neoformans
Device Class
Class II
Regulation Number
866.3165
Review Panel
MI
Submission Type

Other clearances by Immuno-Mycologics, Inc.

  • K120946 — ALPHA CRYPTOCOCCAL ANTIGEN EIA (December 17, 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)
  • K802427 — LA-SPORO ANTIBODY SYSTEM (October 31, 1980)

Other clearances for product code GMD

  • K102286 — CRAG LATERAL FLOW ASSAY (CRAG LFA) (July 20, 2011)
  • K930418 — CRYPTO-LEX SYSTEM (February 17, 1994)
  • K933997 — PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY (November 22, 1993)
  • K894845 — (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE (September 8, 1989)
  • K812188 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI (August 31, 1981)
  • K810510 — YA-CRYPTO ANTIBODY TUBE AGGLUTINATION (March 20, 1981)
  • K792693 — CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX (January 21, 1980)
  • K791382 — CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION (August 16, 1979)
  • K780526 — CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM (April 28, 1978)