ORTHO* RSV ANTIGEN ELISA TEST SYS— 510(k) K842047

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K842047 for ORTHO* RSV ANTIGEN ELISA TEST SYS, Substantially Equivalent on 1984-10-05. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code LKT
Advisory panel: Microbiology
Date received: 1984-05-21
Decision date: 1984-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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