510(k) K872628— GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

Clearance details

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