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

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..

Clearance details

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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.