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510(k) K792410

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

K792410 is an FDA 510(k) premarket notification submitted by Volu Sol Medical Industries for the device "ELVI SGOT & SGPT TRANSAMINASE". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code CIS (Hydrazone Colorimetry, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Volu Sol Medical Industries has at least 10 other 510(k) clearances on record.

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)
  • K822129 — VOLU-SOL BOVINS FIXATIVE (August 5, 1982)
  • K822127 — VOLU-SOL ZENKERS FIXATIVE (August 5, 1982)
  • K822037 — VOLU-SOL TAP WATER SUBSTITUTE (August 3, 1982)
  • K822035 — VOLU-SOL GILLS EA (August 3, 1982)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K822038 — VOLU-SOL ORANGE G-6(GILLS-MOD (August 3, 1982)
  • K812906 — ELVI BICLOT 816 (July 22, 1982)
  • K821540 — HEMATOXYLIN II (June 10, 1982)

Other clearances for product code CIS

  • K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (September 5, 2003)
  • 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)

FDA data resources