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510(k) K830837

LA-HISTO ANTIBODY SYSTEM #HL 1001 by Immuno-Mycologics, Inc. — Product Code GMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1983
Date Received
March 16, 1983
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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Other clearances for product code GMJ

  • 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)
  • K792708 — HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (January 17, 1980)
  • K792704 — HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (January 17, 1980)
  • K792711 — HISTOPLASMA CAPSULATUM, ANTISERUM (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)