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510(k) K813359

MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL by American Scientific Products — Product Code GMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
November 30, 1981
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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  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
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Other clearances for product code GMJ

  • K830837 — LA-HISTO ANTIBODY SYSTEM #HL 1001 (May 5, 1983)
  • K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUM (September 26, 1980)
  • K792701 — HISTOPLASMA CAPSULATUM, ANTIGEN (January 23, 1980)
  • K792711 — HISTOPLASMA CAPSULATUM, ANTISERUM (January 17, 1980)
  • K792704 — HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (January 17, 1980)
  • K792708 — HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (January 17, 1980)
  • K791384 — FUNGAL IMMUNODIFFUSION KIT #ID1001 (August 16, 1979)
  • K791394 — HISTOPLASMA MYCELIAL #CF10020X (August 16, 1979)
  • K791393 — HISTOPLASMA YEAST ANTI #CF10021X (August 16, 1979)
  • K760826 — HISTOPLASMA MYCELIAL ANTIGEN (November 1, 1976)