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510(k) K871211

PROGESTERONE CLASP RADIOIMMUNOASSAY KIT by Biotecx Laboratories, Inc. — Product Code JLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1987
Date Received
March 26, 1987
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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  • K951630 — AURAFLEX PROGESTERONE 150TEST PACK (May 8, 1995)