GENZYME DIAGNOSTICS CONTRAST MONO— 510(k) K963425

Substantially Equivalent

Genzyme Diagnostics

FDA 510(k) clearance K963425 for GENZYME DIAGNOSTICS CONTRAST MONO, Substantially Equivalent on 1997-02-25. Applicant: Genzyme Diagnostics.

Clearance details

Applicant: Genzyme Diagnostics
Product code: Code KTN
Advisory panel: Immunology
Date received: 1996-08-30
Decision date: 1997-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

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