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510(k) K791386

ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM by Immuno-Mycologics, Inc. — Product Code KFG

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
Antiserum, Positive Control, Aspergillus Spp.
Device Class
Class I
Regulation Number
866.3040
Review Panel
MI
Submission Type

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  • K101407 — ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 (July 19, 2011)
  • K883333 — RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT (August 25, 1988)
  • K880029 — EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 (February 24, 1988)
  • K843286 — EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (October 1, 1984)
  • K831918 — LA-STAPH IDENTIFICATION SYSTEM (June 8, 1983)
  • K830837 — LA-HISTO ANTIBODY SYSTEM #HL 1001 (May 5, 1983)
  • K810510 — YA-CRYPTO ANTIBODY TUBE AGGLUTINATION (March 20, 1981)

Other clearances for product code KFG

  • K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (July 1, 1991)
  • K792698 — ASPERGILLUS SP, ANTISERUM, POSITIVE (January 17, 1980)
  • K792686 — ASPERGILLUS SP, ANTISERUM POSITIVE (January 17, 1980)
  • K760835 — ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) (November 1, 1976)