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510(k) K951630

AURAFLEX PROGESTERONE 150TEST PACK by Organon Teknika Corp. — Product Code JLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1995
Date Received
April 7, 1995
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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  • K952075 — PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (June 13, 1995)
  • K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (April 11, 1995)