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510(k) K760830

ASPERGILLUS MYCELIAL ANTIGEN by I M, Inc. — Product Code JWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1976
Date Received
October 13, 1976
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)
  • K791387 — ASPERGILLUS MYCELIAL ANTIGEN #CF10024X (August 16, 1979)
  • K790672 — ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU (May 31, 1979)