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510(k) K914107

PROLACTIN IRMA IMMUNOMAG by Pantex, Div. Bio-Analysis, Inc. — Product Code CFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1991
Date Received
September 13, 1991
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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