RUBINDEX*DIRECT SYSTEM— 510(k) K781638

Substantially Equivalent

Ortho Diagnostics, Inc.

FDA 510(k) clearance K781638 for RUBINDEX*DIRECT SYSTEM, Substantially Equivalent on 1978-12-20. Applicant: Ortho Diagnostics, Inc..

Clearance details

Applicant: Ortho Diagnostics, Inc.
Product code: Code GOK
Advisory panel: Microbiology
Date received: 1978-09-21
Decision date: 1978-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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