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510(k) K902208

MODIFIED OVUGEN by Biogenex Laboratories — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1990
Date Received
May 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
Review Panel
CH
Submission Type

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