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510(k) K920921

ELISA TUBE PROLACTIN TEST KIT by Bio Clinic Co. — Product Code CFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1992
Date Received
February 28, 1992
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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