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510(k) K904219

SYNCHRON CX 7 CLINICAL ANALYZER by Beckman — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1990
Date Received
September 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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  • K935362 — P-AMYLASE CONTROL (January 27, 1994)
  • K904220 — SYNCHRON CX4-CE (October 15, 1990)
  • K893583 — BECKMAN CHOLINESTERASE REAGENT KIT (August 15, 1989)

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