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510(k) K851994

AST ASPARTATE AMINOTRANSFERASE REAGENT by Alpkem Corp. — Product Code CIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1985
Date Received
May 7, 1985
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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  • K890337 — TRIGLYCERIDES - GPO REAGENT (March 9, 1989)
  • K890336 — GLUCOSE (GOD) REAGENT (February 27, 1989)
  • K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (February 17, 1989)
  • K890333 — ALBUMIN REAGENT (February 17, 1989)
  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
  • K883020 — RFA-300 RAPID FLOW ANALYZER W/COMPUTER (September 2, 1988)
  • K860367 — MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) (April 11, 1986)

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