TCI-31 LIFELONG OVULATION TESTER— 510(k) K013323

Substantially Equivalent

Tci New York

FDA 510(k) clearance K013323 for TCI-31 LIFELONG OVULATION TESTER, Substantially Equivalent on 2001-12-05. Applicant: Tci New York. Device class: 1.

Clearance details

Applicant: Tci New York
Product code: Code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 2001-10-05
Decision date: 2001-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.