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510(k) K973310

TBD* ONE-STEP OVULATION PREDICTOR TEST by Armkel, LLC — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1997
Date Received
September 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
Review Panel
CH
Submission Type

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  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)