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510(k) K904499

NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM) by Ackrad Laboratories — Product Code KFG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1991
Date Received
October 1, 1990
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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  • K915813 — ACKRAD ERCP CONTRAST DELIVERY SET (March 11, 1992)
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Other clearances for product code KFG

  • K792698 — ASPERGILLUS SP, ANTISERUM, POSITIVE (January 17, 1980)
  • 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)