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510(k) K812740

REAGENTS FOR SERODIAGNOSIS OF ASPERGILL by Nolan Biological Laboratories, Inc. — Product Code JWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1981
Date Received
September 29, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf, Aspergillus Spp.
Device Class
Class I
Regulation Number
866.3040
Review Panel
MI
Submission Type

Other clearances by Nolan Biological Laboratories, Inc.

  • K812741 — REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS (October 23, 1981)
  • K802130 — IMMUNO. IDENTIFICATION OF H. CAPSULATUM (September 26, 1980)
  • K802129 — IMMUNODIFFUSION REAGENTS/SEROLOGICAL (September 26, 1980)
  • K802128 — IMMUNODIFFUSSION REAGENTS/SEROLOGICAL (September 26, 1980)

Other clearances for product code JWT

  • K792700 — ASPERGILLUS SP, COMPLEMENT FIXATION (January 17, 1980)
  • K791387 — ASPERGILLUS MYCELIAL ANTIGEN #CF10024X (August 16, 1979)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)
  • K760830 — ASPERGILLUS MYCELIAL ANTIGEN (November 1, 1976)