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510(k) K791394

HISTOPLASMA MYCELIAL #CF10020X by Immuno-Mycologics, Inc. — Product Code GMJ

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

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  • K883333 — RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT (August 25, 1988)
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  • K843286 — EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (October 1, 1984)
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  • 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)
  • K792704 — HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (January 17, 1980)
  • K792708 — HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (January 17, 1980)
  • K792711 — HISTOPLASMA CAPSULATUM, ANTISERUM (January 17, 1980)
  • K791384 — FUNGAL IMMUNODIFFUSION KIT #ID1001 (August 16, 1979)
  • K791393 — HISTOPLASMA YEAST ANTI #CF10021X (August 16, 1979)
  • K760827 — HISTOPLASMA YEAST ANTIGEN (November 1, 1976)