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510(k) K802130

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

K802130 is an FDA 510(k) premarket notification submitted by Nolan Biological Laboratories, Inc. for the device "IMMUNO. IDENTIFICATION OF H. CAPSULATUM". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code GMJ (Antigens, Histoplasma Capsulatum, All), a Class II device regulated under 21 CFR 866.3320. Nolan Biological Laboratories, Inc. has at least 4 other 510(k) clearances on record.

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)
  • K792708 — HISTOPLASMA CAPSULATUM, MYCELIAL PHASE (January 17, 1980)
  • K792711 — HISTOPLASMA CAPSULATUM, ANTISERUM (January 17, 1980)
  • K792704 — HISTOPLASMA CAPSULATUM, ANTIGEN YEAST (January 17, 1980)
  • K791394 — HISTOPLASMA MYCELIAL #CF10020X (August 16, 1979)
  • K791384 — FUNGAL IMMUNODIFFUSION KIT #ID1001 (August 16, 1979)
  • K791393 — HISTOPLASMA YEAST ANTI #CF10021X (August 16, 1979)
  • K760826 — HISTOPLASMA MYCELIAL ANTIGEN (November 1, 1976)

FDA data resources