FACT* HOME PREGNANCY TEST— 510(k) K810581

Substantially Equivalent

Ortho Pharmaceutical Corp.

FDA 510(k) clearance K810581 for FACT* HOME PREGNANCY TEST, Substantially Equivalent on 1981-03-17. Applicant: Ortho Pharmaceutical Corp..

Clearance details

Applicant: Ortho Pharmaceutical Corp.
Product code: Code JHJ
Advisory panel: Clinical Chemistry
Date received: 1981-03-03
Decision date: 1981-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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