INVERNESS MEDICAL OVULATION PREDICTOR TEST— 510(k) K002867

Name: FDA 510(k) clearance K002867
Creator: U.S. Food and Drug Administration
Published: 2000-10-12

Substantially Equivalent

Selfcare, Inc.

FDA 510(k) clearance K002867 for INVERNESS MEDICAL OVULATION PREDICTOR TEST, Substantially Equivalent on 2000-10-12. 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: 2000-09-13
Decision date: 2000-10-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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