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510(k) K971921

PROLACTIN (PRL) HORMONE MICROPLATE ELISA by Monobind — Product Code CFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1997
Date Received
May 23, 1997
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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