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510(k) K872862

PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS by Serono Diagnostics, Inc. — Product Code CFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1987
Date Received
July 21, 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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  • K882340 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (August 8, 1988)
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  • K873431 — PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (October 20, 1987)
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