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510(k) K802130

IMMUNO. IDENTIFICATION OF H. CAPSULATUM by Nolan Biological Laboratories, Inc. — Product Code GMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
August 4, 1980
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

Other clearances by Nolan Biological Laboratories, Inc.

  • K812741 — REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS (October 23, 1981)
  • K812740 — REAGENTS FOR SERODIAGNOSIS OF ASPERGILL (October 20, 1981)
  • K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL (September 26, 1980)
  • K802128 — IMMUNODIFFUSSION REAGENTS/SEROLOGICAL (September 26, 1980)

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)
  • K792701 — HISTOPLASMA CAPSULATUM, ANTIGEN (January 23, 1980)
  • K792711 — HISTOPLASMA CAPSULATUM, ANTISERUM (January 17, 1980)
  • K792708 — HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (January 17, 1980)
  • K792704 — HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (January 17, 1980)
  • K791384 — FUNGAL IMMUNODIFFUSION KIT #ID1001 (August 16, 1979)
  • K791393 — HISTOPLASMA YEAST ANTI #CF10021X (August 16, 1979)
  • K791394 — HISTOPLASMA MYCELIAL #CF10020X (August 16, 1979)
  • K760827 — HISTOPLASMA YEAST ANTIGEN (November 1, 1976)