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510(k) K890023

HDL CHOLESTEROL REAGENT (PTA/MGCL2) by Sigma Diagnostics, Inc. — Product Code LBR

K890023 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "HDL CHOLESTEROL REAGENT (PTA/MGCL2)". The FDA issued a decision of Substantially Equivalent on Feb 17, 1989. The device falls under product code LBR (Ldl & Vldl Precipitation, Hdl), a Class I device regulated under 21 CFR 862.1475. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 17, 1989
Date Received
Jan 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Ldl & Vldl Precipitation, Hdl
Device Class
Class I
Regulation Number
862.1475
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 LBR

  • K143691 — LDLC3 LDL-Cholesterol Gen.3 (Jan 28, 2015)
  • K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS (Jan 22, 2008)
  • K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR (Jul 26, 2005)
  • K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA… (Dec 24, 2002)
  • K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY… (Aug 30, 2001)
  • K992029 — ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (Aug 12, 1999)
  • K992002 — AUTOHDL CHOLESTEROL REAGENT SET (Aug 5, 1999)
  • K991789 — ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS (Jul 9, 1999)
  • K990247 — MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 (May 28, 1999)
  • K984303 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT (Jan 28, 1999)

FDA data resources

Source: FDA 510(k) database entry for K890023. Report a data issue: hello@regdatalab.com.