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510(k) K893641

COBAS FARA CENTRIFUGAL ANALYZER by Roche Diagnostic Systems, Inc. — Product Code JJG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1989
Date Received
May 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class
Class I
Regulation Number
862.2140
Review Panel
CH
Submission Type

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  • K983555 — ABUSCREEN ONLINE BENZ 200 CALIBRATORS (December 15, 1998)
  • K983556 — ABUSCREEN ONLINE BENZ 300 CALIBRATORS (December 15, 1998)
  • K983703 — MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE (December 11, 1998)
  • K983697 — MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE (December 11, 1998)
  • K983699 — MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES (December 11, 1998)
  • K983700 — MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE (December 11, 1998)
  • K983701 — MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS (December 11, 1998)

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  • K934592 — EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR (April 6, 1994)
  • K920942 — OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER (June 10, 1992)
  • K910222 — COBAS ALPHA (February 27, 1991)
  • K903626 — BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA (October 15, 1990)
  • K893854 — COBAS FARA II CENTRIFUGAL ANALYZER (August 3, 1989)
  • K885203 — TECHNICON DAX(TM) SYSTEM (March 28, 1989)
  • K871973 — IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (June 11, 1987)
  • K871838 — BIOMEK 1000C AUTOMATED LABORATORY WORK STATION (May 26, 1987)