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510(k) K800689

REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- by Diagnostic Solutions, Inc. — Product Code CKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1980
Date Received
March 26, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Diagnostic Solutions, Inc.

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  • K921825 — QUICK-CHECK II REAGENT STRIP (August 18, 1992)
  • K800681 — REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (May 30, 1980)
  • K800679 — REAGENTS FOR DETERM. ALKALINE PHOSPHATAS (May 28, 1980)
  • K800687 — REAGENT FOR DETERM. GLUCOSE IN H/SERUM (May 28, 1980)
  • K800682 — REAGENTS FOR DETERM. CHOLESTEROL/SERUM (May 28, 1980)
  • K800674 — SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER (May 28, 1980)
  • K800676 — REAGENTS FOR DETERM. SODIUM IN HUMAN SUM (May 28, 1980)
  • K800692 — REAGENT FOR DETERM. POTASSIUM/IN HUMAN (May 28, 1980)

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  • K020487 — CARESIDE ALT (June 4, 2002)
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  • K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA (January 7, 1998)
  • K974003 — ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (December 5, 1997)
  • K971323 — ALT OR SGPT (April 21, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)