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510(k) K922715

IMMUCHEM PRL-MW ELISA by Icn Biomedicals, Inc. — Product Code CFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1992
Date Received
June 5, 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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