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510(k) K855189

GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET by Technostics Intl. — Product Code CIQ

K855189 is an FDA 510(k) premarket notification submitted by Technostics Intl. for the device "GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 14, 1986. The device falls under product code CIQ (Diazo, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Technostics Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1986
Date Received
December 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Technostics Intl.

  • K855188 — CPK (UV) REAGENT KIT (March 5, 1986)
  • K860111 — URIC ACID REAGENT SET (February 19, 1986)
  • K855190 — MAGNESIUM REAGENT SET (February 18, 1986)
  • K860110 — GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET (February 11, 1986)
  • K860109 — ENZYMATIC UREA NITROGEN REAGENT SET (February 6, 1986)
  • K860112 — TOTAL LIPIDS REAGENT SET (January 24, 1986)
  • K855185 — GLUCOSE REAGENT SET (January 22, 1986)
  • K855157 — LACTIC DEHYDROGENASE (VV) REAGENT SET (January 21, 1986)
  • K855154 — INORGANIC PHOSPHORUS REAGENT SET (January 14, 1986)
  • K855193 — CREATININE REAGENT SET (January 14, 1986)

Other clearances for product code CIQ

  • K881173 — ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (June 7, 1988)
  • K860216 — SGOT (AST) REAGENT SET (April 3, 1986)
  • K844322 — SGOT REAGENT SET (November 27, 1984)
  • K841065 — SGOT REAGENT SET (May 1, 1984)
  • K821209 — SGOT REAGENT SET (July 14, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)

FDA data resources