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510(k) K894049

IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT by Pantex, Div. Bio-Analysis, Inc. — Product Code JLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1989
Date Received
June 7, 1989
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)