510(k) K062703— ONE STEP HCG PREGNANCY TEST

Substantially Equivalent

Ai DE Diagnostic Co., Ltd.

Clearance details

Applicant: Ai DE Diagnostic Co., Ltd.
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 2006-09-11
Decision date: 2007-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iowa City, IA, US

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