EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)— 510(k) K991386

Name: FDA 510(k) clearance K991386
Creator: U.S. Food and Drug Administration
Published: 1999-05-25

Substantially Equivalent

Selfcare, Inc.

FDA 510(k) clearance K991386 for EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK), Substantially Equivalent on 1999-05-25. Applicant: Selfcare, Inc.. Device class: 1.

Clearance details

Applicant: Selfcare, Inc.
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1999-04-21
Decision date: 1999-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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