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510(k) K792410

ELVI SGOT & SGPT TRANSAMINASE by Volu Sol Medical Industries — Product Code CIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
November 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hydrazone Colorimetry, Ast/Sgot
Device Class
Class II
Regulation Number
862.1100
Review Panel
CH
Submission Type

Other clearances by Volu Sol Medical Industries

  • K822128 — VOLU-SOL SINGLE DIFFERENTIAL STAIN (August 5, 1982)
  • K822126 — VOLU-SOL CARNOY FLUID (August 5, 1982)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821533 — HEMATOXYLIN I (June 10, 1982)

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  • K896238 — COBAS READY AST REAGENT (February 16, 1990)
  • K854187 — IN-VITRO TEST DETERMINATION OF SGOT (AST) (November 25, 1985)
  • K812872 — OPTIONAL TOTAL CA-MODULE FOR IL 504/508 (October 26, 1981)