ORTHO* ROTAVIRUS ANTIGEN ELISA TEST— 510(k) K883935

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K883935 for ORTHO* ROTAVIRUS ANTIGEN ELISA TEST, Substantially Equivalent on 1989-01-04. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code LIQ
Advisory panel: Microbiology
Date received: 1988-09-19
Decision date: 1989-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

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