ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY— 510(k) K884617

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K884617 for ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY, Substantially Equivalent on 1989-02-02. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code LFX
Advisory panel: Microbiology
Date received: 1988-11-04
Decision date: 1989-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

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