Home / 510(k) Clearances / K854502

510(k) K854502

ALT(OPTIMIZED) REAGENT by Sigma Diagnostics, Inc. — Product Code CKA

K854502 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "ALT(OPTIMIZED) REAGENT". The FDA issued a decision of Substantially Equivalent on Nov 25, 1985. The device falls under product code CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 25, 1985
Date Received
Nov 12, 1985
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
510(k) Exempt

Other clearances by Sigma Diagnostics, Inc.

  • K021162 — AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX… (Aug 30, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (Feb 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (Dec 26, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (Nov 15, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (Nov 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (Oct 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (Mar 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (Mar 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (Mar 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (Mar 1, 2001)

Other clearances for product code CKA

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

FDA data resources

Source: FDA 510(k) database entry for K854502. Report a data issue: hello@regdatalab.com.