K123703

Substantially Equivalent

HEALGEN HCG ONE STEP PREGNANCY TEST (STRIP), HEALGEN HCG ONE STEP PREGNANCY TEST (CASSETTE)

Applicant: Healgen Scientific,, LLC
Product code: LCX
Advisory panel: Clinical Chemistry
Date received: 2012-12-03
Decision date: 2013-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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