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510(k) K854187

IN-VITRO TEST DETERMINATION OF SGOT (AST) by Clinical Data, Inc. — Product Code CIS

K854187 is an FDA 510(k) premarket notification submitted by Clinical Data, Inc. for the device "IN-VITRO TEST DETERMINATION OF SGOT (AST)". The FDA issued a decision of Substantially Equivalent on November 25, 1985. The device falls under product code CIS (Hydrazone Colorimetry, Ast/Sgot), a Class II device regulated under 21 CFR 862.1100. Clinical Data, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1985
Date Received
October 15, 1985
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 Clinical Data, Inc.

  • K071706 — ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55 (December 20, 2007)
  • K052591 — NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT (February 9, 2006)
  • K033983 — VITALAB IRON REAGENT (May 21, 2004)
  • K040631 — VITALAB DIRECT BILIRUBIN REAGENT (March 18, 2004)
  • K040534 — VITALAB AMYLASE REAGENT (March 11, 2004)
  • K034000 — VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR (March 10, 2004)
  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K040508 — VITALAB MAGNESIUM REAGENT (March 8, 2004)
  • K031042 — ATAC HEMOGLOBIN A1C REAGENT KIT (November 3, 2003)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)

Other clearances for product code CIS

  • K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (September 5, 2003)
  • K896238 — COBAS READY AST REAGENT (February 16, 1990)
  • K812872 — OPTIONAL TOTAL CA-MODULE FOR IL 504/508 (October 26, 1981)
  • K792410 — ELVI SGOT & SGPT TRANSAMINASE (December 6, 1979)

FDA data resources