MODIFIED IMAGEN(TM) CHLAMYDIA TEST— 510(k) K864539

Substantially Equivalent

Boots-Celltech Diagnostics, Inc.

FDA 510(k) clearance K864539 for MODIFIED IMAGEN(TM) CHLAMYDIA TEST, Substantially Equivalent on 1987-03-12. Applicant: Boots-Celltech Diagnostics, Inc..

Clearance details

Applicant: Boots-Celltech Diagnostics, Inc.
Product code: Code LJP
Advisory panel: Microbiology
Date received: 1986-11-19
Decision date: 1987-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berkshire, England, GB

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