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510(k) K771591

MINISTAT-S CHEMISTRY ANALYZER by Biokinetix Corp. — Product Code JJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1977
Date Received
August 19, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Enzyme, For Clinical Use
Device Class
Class I
Regulation Number
862.2500
Review Panel
CH
Submission Type

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