ORTHO CMV-M ANTIBODY ELISA TEST— 510(k) K905077

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K905077 for ORTHO CMV-M ANTIBODY ELISA TEST, Substantially Equivalent on 1990-12-17. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant
Ortho Diagnostic Systems, Inc.
Product code
Code LFZ
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Carpinteria, CA, US
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