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510(k) K022519

LDL CHOLESTEROL (AUTOMATED) by Jas Diagnostics, Inc. — Product Code JHM

K022519 is an FDA 510(k) premarket notification submitted by Jas Diagnostics, Inc. for the device "LDL CHOLESTEROL (AUTOMATED)". The FDA issued a decision of Substantially Equivalent on September 30, 2002. The device falls under product code JHM (Colorimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Jas Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2002
Date Received
July 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimetric Method, Lipoproteins
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

Other clearances by Jas Diagnostics, Inc.

  • K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK (May 15, 2014)
  • K080623 — CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA (November 17, 2008)
  • K080618 — DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID (May 23, 2008)
  • K021671 — JAS HDL CHOLESTEROL (AUTOMATED) REAGENT (July 19, 2002)
  • K020454 — CHEMISTRY CALIBRATOR (April 8, 2002)
  • K020282 — JAS AMYLASE LIQUID REAGENT (February 28, 2002)
  • K013912 — CREATINE KINASE (CK-NAC) (January 18, 2002)
  • K013698 — AST (SGOT) (December 21, 2001)
  • K012332 — JAS CARBON DIOXIDE LIQUID REAGENT (September 6, 2001)
  • K012038 — JAS URIC ACID LIQUID REAGENT (August 21, 2001)

Other clearances for product code JHM

  • K120662 — PICCOLO HDL-CAPILLARY TEST SYSTEM (April 24, 2012)
  • K081300 — DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE (July 2, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K032798 — DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALO (October 30, 2003)
  • K983849 — DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CAR (January 11, 1999)
  • K902935 — ROCHE COBAS READY HDL CHOLESTEROL REAGENT (September 27, 1990)
  • K841056 — HDL PRECIPITANT REAGENT SET (May 1, 1984)
  • K780173 — LYPOPROTEIN CHOLESTEROL TEST KIT (May 3, 1978)

FDA data resources