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510(k) K791387

ASPERGILLUS MYCELIAL ANTIGEN #CF10024X by Immuno-Mycologics, Inc. — Product Code JWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1979
Date Received
July 11, 1979
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

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Other clearances for product code JWT

  • K812740 — REAGENTS FOR SERODIAGNOSIS OF ASPERGILL (October 20, 1981)
  • K792700 — ASPERGILLUS SP, COMPLEMENT FIXATION (January 17, 1980)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)
  • K760830 — ASPERGILLUS MYCELIAL ANTIGEN (November 1, 1976)