WELLCOLEX E-COLI OI57 ZC60— 510(k) K962028

Substantially Equivalent

Murex Diagnostics, Inc.

FDA 510(k) clearance K962028 for WELLCOLEX E-COLI OI57 ZC60, Substantially Equivalent on 1996-11-01. Applicant: Murex Diagnostics, Inc..

Clearance details

Applicant: Murex Diagnostics, Inc.
Product code: Code GNA
Advisory panel: Microbiology
Date received: 1996-05-23
Decision date: 1996-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

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