MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES— 510(k) K854615

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K854615 for MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES, Substantially Equivalent on 1986-01-28. Applicant: Serono Diagnostics, Inc..

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code LKI
Advisory panel: Microbiology
Date received: 1985-11-18
Decision date: 1986-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bramtree, MA, US

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