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510(k) K952075

PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM by Bayer Corp. — Product Code JLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1995
Date Received
May 3, 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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  • K955025 — AXSYM PROGESTERONE (March 7, 1996)
  • K955769 — ACCESS PROGESTERONE ASSAY (February 5, 1996)
  • K951630 — AURAFLEX PROGESTERONE 150TEST PACK (May 8, 1995)
  • K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (April 11, 1995)