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510(k) K120946

ALPHA CRYPTOCOCCAL ANTIGEN EIA by Immuno-Mycologics, Inc. — Product Code MDU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2012
Date Received
March 29, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Elisa, Cryptococcus
Device Class
Class II
Regulation Number
866.3165
Review Panel
MI
Submission Type

Other clearances by Immuno-Mycologics, Inc.

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  • 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 MDU

  • K904393 — PREMIER-CRYPTOCOCCAL ANTIGEN (January 25, 1991)