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510(k) K771813

CENTRIFICHEM SYS 400 ANALYZER by Clinical Diagnostics, Inc. — Product Code JJG

K771813 is an FDA 510(k) premarket notification submitted by Clinical Diagnostics, Inc. for the device "CENTRIFICHEM SYS 400 ANALYZER". The FDA issued a decision of Substantially Equivalent on October 25, 1977. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140. Clinical Diagnostics, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1977
Date Received
September 27, 1977
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

Other clearances by Clinical Diagnostics, Inc.

  • K971653 — GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM (January 2, 1998)
  • K951457 — GLUCOCHEK POCKETLAB (February 22, 1996)
  • K940215 — GLUCOCHEK (January 17, 1995)
  • K854903 — GORDON DIAGNOSTIC SYSTEM MODEL I (June 2, 1986)
  • K771118 — CENTRIA SEPARATION COLUMNS TYPE A (July 11, 1977)
  • K771117 — CENTRIA CORTISOL RIA (June 23, 1977)
  • K761272 — CENTRIA T4 RIA (March 16, 1977)

Other clearances for product code JJG

  • K972409 — AG CHEMISTRY ANALYZER SYSTEM (August 28, 1997)
  • K942782 — PICCOLO(TM) (March 13, 1995)
  • 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)
  • K893641 — COBAS FARA CENTRIFUGAL ANALYZER (July 20, 1989)
  • K885203 — TECHNICON DAX(TM) SYSTEM (March 28, 1989)
  • K871973 — IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (June 11, 1987)

FDA data resources