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510(k) K851619

GEN PROFILER SYSTEM by Electro-Cucleonics, Inc. — Product Code JJG

K851619 is an FDA 510(k) premarket notification submitted by Electro-Cucleonics, Inc. for the device "GEN PROFILER SYSTEM". The FDA issued a decision of Substantially Equivalent on May 14, 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
May 14, 1985
Date Received
April 18, 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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  • 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