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510(k) K820491

SGPT REAGENT SET by Anco Medical Reagents & Assoc. — Product Code CKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1982
Date Received
February 23, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrazone Colorimetry, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
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)
  • K820466 — SGOT REAGENT SET (March 11, 1982)
  • K812837 — ALKALINE PHOSPHATASE REAGENT SET (January 29, 1982)
  • K813415 — UREA NITROGEN REAGENT SET (December 31, 1981)

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  • K896237 — COBAS READY ALT REAGENT (February 16, 1990)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K864082 — REFLOTRON(R) ALT (GPT) (December 4, 1986)
  • K860485 — SGPT (ALT) REAGENT SET (COLORIMETRIC) (April 3, 1986)
  • K844283 — SGPT REAGENT SET (November 27, 1984)
  • K841059 — SGPT REAGENT SET (May 1, 1984)
  • K821207 — SGPT REAGENT SET (July 14, 1982)