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510(k) K792698

ASPERGILLUS SP, ANTISERUM, POSITIVE by Meridian Diagnostics, Inc. — Product Code KFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1980
Date Received
December 27, 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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Other clearances for product code KFG

  • K904499 — NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) (July 1, 1991)
  • K792686 — ASPERGILLUS SP, ANTISERUM POSITIVE (January 17, 1980)
  • K791386 — ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM (August 16, 1979)
  • K760835 — ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) (November 1, 1976)