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510(k) K902935

ROCHE COBAS READY HDL CHOLESTEROL REAGENT by Roche Diagnostic Systems, Inc. — Product Code JHM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1990
Date Received
July 3, 1990
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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  • K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS (December 15, 1998)
  • K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (December 11, 1998)
  • K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (December 11, 1998)
  • K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (December 11, 1998)
  • K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (December 11, 1998)
  • K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (December 11, 1998)

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)
  • K022519 — LDL CHOLESTEROL (AUTOMATED) (September 30, 2002)
  • K983849 — DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CAR (January 11, 1999)
  • K841056 — HDL PRECIPITANT REAGENT SET (May 1, 1984)
  • K780173 — LYPOPROTEIN CHOLESTEROL TEST KIT (May 3, 1978)