GLYCOMARK— 510(k) K031604

Substantially Equivalent

Tomen America, Inc.

FDA 510(k) clearance K031604 for GLYCOMARK, Substantially Equivalent on 2003-09-22. Applicant: Tomen America, Inc..

Clearance details

Applicant: Tomen America, Inc.
Product code: Code NOZ
Advisory panel: Hematology
Date received: 2003-05-22
Decision date: 2003-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

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