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510(k) K941314

STANBIO ALT/GPT (LUQUI-UV) TEST SET by Stanbio Laboratory — Product Code CKA

K941314 is an FDA 510(k) premarket notification submitted by Stanbio Laboratory for the device "STANBIO ALT/GPT (LUQUI-UV) TEST SET". The FDA issued a decision of Substantially Equivalent on July 20, 1994. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Stanbio Laboratory has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1994
Date Received
March 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Stanbio Laboratory

  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (June 10, 2009)
  • K081719 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (July 18, 2008)
  • K050266 — DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR (June 30, 2005)
  • K050283 — CREATININE LIQUICOLOR (June 30, 2005)
  • K042169 — STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER (March 14, 2005)
  • K041155 — WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY (October 14, 2004)
  • K032936 — DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIB (March 12, 2004)
  • K032932 — DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTEROL CALIBRATOR (March 10, 2004)
  • K032482 — STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM (October 24, 2003)
  • K020378 — QUPID PLUS E.R. (June 21, 2002)

Other clearances for product code CKA

  • K120945 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZE (June 7, 2013)
  • K113382 — ACE ALT REAGENT (July 19, 2012)
  • K061020 — DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARB (May 10, 2006)
  • K020487 — CARESIDE ALT (June 4, 2002)
  • K980028 — ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (February 2, 1998)
  • K973869 — TRACE REAGENT LINE FOR THE COBAS MIRA (January 7, 1998)
  • K974003 — ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30 (December 5, 1997)
  • K971323 — ALT OR SGPT (April 21, 1997)
  • K965134 — ALT/SGPT (February 18, 1997)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)

FDA data resources