OVUTIME OVULATION PREDICTOR TEST— 510(k) K853142

Name: FDA 510(k) clearance K853142
Creator: U.S. Food and Drug Administration
Published: 1985-12-17

Substantially Equivalent

Advanced Care Products

FDA 510(k) clearance K853142 for OVUTIME OVULATION PREDICTOR TEST, Substantially Equivalent on 1985-12-17. Applicant: Advanced Care Products. Device class: 1.

Clearance details

Applicant: Advanced Care Products
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1985-07-29
Decision date: 1985-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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