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510(k) K802128

IMMUNODIFFUSSION REAGENTS/SEROLOGICAL by Nolan Biological Laboratories, Inc. — Product Code JWW

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
Antigen, Cf, B. Dermatitidis
Device Class
Class II
Regulation Number
866.3060
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)
  • K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUM (September 26, 1980)
  • K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL (September 26, 1980)

Other clearances for product code JWW

  • K792683 — BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION (January 23, 1980)
  • K792680 — BLASTOMYCES DERMATITIDIS, ANTIGEN (January 17, 1980)