BACT/ALERT CSR— 510(k) K003104

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K003104 for BACT/ALERT CSR, Substantially Equivalent on 2000-10-20. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code LJF
Advisory panel: Microbiology
Date received: 2000-08-29
Decision date: 2000-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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