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

Name: FDA 510(k) clearance K854615
Creator: U.S. Food and Drug Administration
Published: 1986-01-28

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.. Device class: 1.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code LKI
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1985-11-18
Decision date: 1986-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bramtree, MA, US

Download summary PDF View on FDA.gov ↗

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