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510(k) K812834

CREATININE REAGENT SET by Anco Medical Reagents & Assoc. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1981
Date Received
October 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Anco Medical Reagents & Assoc.

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  • K821658 — HEMOGLOBIN REAGENT (June 25, 1982)
  • K821526 — ACID PHOSPHATASE REAGENT SET (June 10, 1982)
  • K821102 — MEGNESIUM REAGENT KIT (May 5, 1982)
  • K820951 — ENZYMATIC CHOLESTEROL KIT (April 26, 1982)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)
  • K820491 — SGPT REAGENT SET (March 11, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)
  • K812837 — ALKALINE PHOSPHATASE REAGENT SET (January 29, 1982)

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