Home / 510(k) Clearances / K101407

510(k) K101407

ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 by Immuno-Mycologics, Inc. — Product Code MIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2011
Date Received
May 19, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
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)
  • 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 MIZ

  • K915700 — PERMIER HISTOPLASMA (July 30, 1992)