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510(k) K883533

ABC FP ANALYZER by Intl. Bioclinical, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1988
Date Received
August 18, 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 Intl. Bioclinical, Inc.

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  • K911688 — INNOFLUOR(TM) VALPROIC ACID REAGENT SET (July 5, 1991)
  • K911466 — INNOFLUOR VALPROIC ACID CALIBRATOR SET (May 23, 1991)
  • K864156 — PROGESTERONE SYSTEM BY EIA (November 24, 1986)

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