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510(k) K822494

OPTIMIZED UV-GPT REAGENT SET by Biorent Diagnostic, Inc. — Product Code CKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1982
Date Received
August 18, 1982
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 Biorent Diagnostic, Inc.

  • K832747 — ALBUMIN REAGENT SET (October 14, 1983)
  • K823060 — HEMOGLOBIN REAGENT (November 22, 1982)
  • K823211 — CK-UV REAGENT (November 22, 1982)
  • K822493 — OPTIMIZED UV-GOT REAGENT SET (September 21, 1982)
  • K822492 — OPTIMIZED UV-LDH REAGENT SET (September 17, 1982)
  • K820768 — COLORIMETRIC LDH REAGENT SET (April 14, 1982)
  • K820632 — COLORIMETRIC URIC ACID REAGENT SET (March 25, 1982)
  • K813555 — GLUCOSE ENZYME-COLOR REAGENT SET (January 18, 1982)
  • K813244 — UV URIC ACID DETERMINATION (December 8, 1981)
  • K811760 — CHOLESTEROL DETERMINATION (July 10, 1981)

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  • K961123 — ALT INCORPORATING DST (April 25, 1996)