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510(k) K882081

SPECIFIC CHEMISTRY ANALYZER by The Rupp & Bowman Co. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1988
Date Received
May 17, 1988
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

Other clearances by The Rupp & Bowman Co.

  • K880973 — MICROLYTE 7 (September 7, 1988)
  • K880242 — KONE CALCIUM TEST (March 15, 1988)

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