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510(k) K803216

CENTRIFICHEM AST/SGOT OPTIMIZED REAGENT by Union Carbide Corp. — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1981
Date Received
December 18, 1980
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

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  • K810732 — LINDE MARK II OXYGEN RESERV. TYPE OR-4 (March 27, 1981)
  • K810596 — CENTRIFI CHEM SYSTEM 400 ANALYZER (March 17, 1981)
  • K810129 — CENTRIFICHEM SYSTEM 500 (February 2, 1981)
  • K802741 — CENTRIFICHEM COMB. SERUM-BASED CALIB. (December 10, 1980)
  • K802520 — CENTRIFICHEM PIPETTOR ACCURACY CALIB. (November 12, 1980)
  • K802436 — CENTRIFICHEM ALBUMIN (October 31, 1980)

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