EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229— 510(k) K011347

Substantially Equivalent

Syva Co.

FDA 510(k) clearance K011347 for EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229, Substantially Equivalent on 2001-05-17. Applicant: Syva Co..

Clearance details

Applicant: Syva Co.
Product code: Code DIP
Advisory panel: Clinical Toxicology
Date received: 2001-05-02
Decision date: 2001-05-17
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

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