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510(k) K881173

ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) by Tech-Co, Inc. — Product Code CIQ

K881173 is an FDA 510(k) premarket notification submitted by Tech-Co, Inc. for the device "ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)". The FDA issued a decision of Substantially Equivalent on June 7, 1988. The device falls under product code CIQ (Diazo, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Tech-Co, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1988
Date Received
March 18, 1988
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 Tech-Co, Inc.

  • K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (June 28, 1996)
  • K923376 — VISUAL HCG PREGNANCY TEST (October 1, 1992)
  • K920766 — T4 EIA BEAD ASSAY (April 17, 1992)
  • K920716 — DIRECT PREGNANCY TEST (March 24, 1992)
  • K902574 — POTASSIUM REAGENT SET (July 10, 1990)
  • K901561 — IRON/TOTAL IRON BINDING CAPACITY (May 17, 1990)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K883683 — HEMOGLOBIN (October 6, 1988)
  • K883386 — CHLORIDE (October 6, 1988)
  • K881172 — BILIRUBIN (DIRECT) (June 7, 1988)

Other clearances for product code CIQ

  • K860216 — SGOT (AST) REAGENT SET (April 3, 1986)
  • K855189 — GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET (January 14, 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