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510(k) K032798

DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A by Dade Behring, Inc. — Product Code JHM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2003
Date Received
September 9, 2003
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

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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)
  • K022519 — LDL CHOLESTEROL (AUTOMATED) (September 30, 2002)
  • 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)