510(k) K964108— FACT PLUS PREGNANCY TEST

Substantially Equivalent

Direct Access Diagnostics

Clearance details

Applicant: Direct Access Diagnostics
Product code: Code LCX
Advisory panel: Clinical Chemistry
Date received: 1996-10-15
Decision date: 1996-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgewater, NJ, US

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