WELLCOLEX E.COLI O157:H7— 510(k) K971663

Substantially Equivalent

Murex Biotech , Ltd.

FDA 510(k) clearance K971663 for WELLCOLEX E.COLI O157:H7, Substantially Equivalent on 1997-12-30. Applicant: Murex Biotech , Ltd.. Device class: 1.

Clearance details

Applicant: Murex Biotech , Ltd.
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1997-05-06
Decision date: 1997-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dartford,Kent, GB

Download summary PDF View on FDA.gov ↗

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