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510(k) K841333

PROGESTERONE DIRECT RIA KIT-RADIOIMM by Biotecx Laboratories, Inc. — Product Code JLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
April 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Progesterone
Device Class
Class I
Regulation Number
862.1620
Review Panel
CH
Submission Type

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