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510(k) K854055

I.C.L.S. COMPULYZER by Integrated Computerized Laboratory Systems, Inc. — Product Code JJG

K854055 is an FDA 510(k) premarket notification submitted by Integrated Computerized Laboratory Systems, Inc. for the device "I.C.L.S. COMPULYZER". The FDA issued a decision of Substantially Equivalent on November 19, 1985. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1985
Date Received
October 3, 1985
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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  • 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