ONE-STEP PREGNANCY TEST— 510(k) K031271

Name: FDA 510(k) clearance K031271
Creator: U.S. Food and Drug Administration
Published: 2003-06-17

Substantially Equivalent

Amerisource Pharmacal, Inc.

FDA 510(k) clearance K031271 for ONE-STEP PREGNANCY TEST, Substantially Equivalent on 2003-06-17. Applicant: Amerisource Pharmacal, Inc.. Device class: 2.

Clearance details

Applicant: Amerisource Pharmacal, Inc.
Product code: Code LCX
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 2003-04-22
Decision date: 2003-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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