AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR— 510(k) K033860

Substantially Equivalent

Wako Chemicals USA, Inc.

FDA 510(k) clearance K033860 for AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR, Substantially Equivalent on 2004-04-23. Applicant: Wako Chemicals USA, Inc..

Clearance details

Applicant: Wako Chemicals USA, Inc.
Product code: Code JIT
Advisory panel: Clinical Chemistry
Date received: 2003-12-12
Decision date: 2004-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, US

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