K883940

Substantially Equivalent

ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST

Applicant: Ortho Diagnostic Systems, Inc.
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.