DBEST ONE-STEP OVULATION TEST— 510(k) K974508

Substantially Equivalent

Ameritek, Inc.

FDA 510(k) clearance K974508 for DBEST ONE-STEP OVULATION TEST, Substantially Equivalent on 1998-02-02. Applicant: Ameritek, Inc.. Device class: 1.

Clearance details

Applicant: Ameritek, Inc.
Product code: Product code CEP
Device class: Class 1
Regulation: 21 CFR 862.1485
Advisory panel: Clinical Chemistry
Date received: 1997-12-01
Decision date: 1998-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, 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.