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510(k) K081300

DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE by Siemens Healthcare Diagnostics — Product Code JHM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2008
Date Received
May 8, 2008
Clearance Type
Special
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

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  • K032798 — DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALO (October 30, 2003)
  • 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)