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510(k) K874621

FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201 by Cyberfluor, Inc. — Product Code CFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1988
Date Received
November 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Prolactin (Lactogen)
Device Class
Class I
Regulation Number
862.1625
Review Panel
CH
Submission Type

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