Elecsys Syphilis— 510(k) K211302

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K211302 for Elecsys Syphilis, Substantially Equivalent on 2021-07-20. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LIP
Advisory panel: Microbiology
Date received: 2021-04-29
Decision date: 2021-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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