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510(k) K970467

EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT by Excel Scientific, Inc. — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1997
Date Received
February 7, 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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  • K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (October 7, 1996)
  • K962580 — EZ SURE ONESTEP EARLY PREGNANCY TEST (August 29, 1996)
  • K955707 — ONESTEP URINE/SERUM HCG MODULE PREGNANCY TEST KIT (May 2, 1996)

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