MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST— 510(k) K870946

Name: FDA 510(k) clearance K870946
Creator: U.S. Food and Drug Administration
Published: 1987-04-29

Substantially Equivalent

Serono Diagnostics, Inc.

FDA 510(k) clearance K870946 for MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST, Substantially Equivalent on 1987-04-29. Applicant: Serono Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Serono Diagnostics, Inc.
Product code: Code LJP
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1987-03-09
Decision date: 1987-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwell, MA, US

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