EARLYDETECT MENOPAUSE TEST FOR FSH— 510(k) K030058

Name: FDA 510(k) clearance K030058
Creator: U.S. Food and Drug Administration
Published: 2003-07-30

Substantially Equivalent

Early Detect, Inc.

FDA 510(k) clearance K030058 for EARLYDETECT MENOPAUSE TEST FOR FSH, Substantially Equivalent on 2003-07-30. Applicant: Early Detect, Inc.. Device class: 1.

Clearance details

Applicant: Early Detect, Inc.
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 2003-01-07
Decision date: 2003-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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