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510(k) K842521

AST/GOT REAGENT SET UV RATE by Sterling Biochemical, Inc. — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1984
Date Received
June 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
Review Panel
CH
Submission Type

Other clearances by Sterling Biochemical, Inc.

  • K844998 — GLUCOSE(HEXOKINASE) REAGENT SET (January 18, 1985)
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  • K843332 — ALKALINE PHOSPHATASE REAGENT SET (September 14, 1984)
  • K840064 — UREA NITROGEN REAGENT SET (June 14, 1984)
  • K834084 — HYDROXYBUTYRATE DEHYDROGENASE REAGENT (February 4, 1984)
  • K834045 — URIC ACID REAGENT SET (January 30, 1984)
  • K833864 — AMYLASE REAGENT SET-MODIFIED CARAWAY (January 13, 1984)
  • K833062 — SERUM CHOLINESTERASE REAGENT SET (November 25, 1983)
  • K831874 — LIPASE REAGENT SET (August 12, 1983)
  • K831415 — LACTIC DEHYDROGENASE REAGENT SET (June 16, 1983)

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