PREGNANCY, SENSIDEX TUBE TEST— 510(k) K782063

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K782063 for PREGNANCY, SENSIDEX TUBE TEST, Substantially Equivalent on 1979-04-04. Applicant: Ortho Diagnostics, Inc..

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code JHJ
Advisory panel: Clinical Chemistry
Date received: 1978-12-11
Decision date: 1979-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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