WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR— 510(k) K061775

Substantially Equivalent

Wako Chemicals USA, Inc.

FDA 510(k) clearance K061775 for WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR, Substantially Equivalent on 2007-02-23. Applicant: Wako Chemicals USA, Inc..

Clearance details

Applicant: Wako Chemicals USA, Inc.
Product code: Code JFY
Advisory panel: Clinical Chemistry
Date received: 2006-06-23
Decision date: 2007-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

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