EMIT CONVENIENCE PACK: PHENYTOIN ASSAY— 510(k) K874856

Name: FDA 510(k) clearance K874856
Creator: U.S. Food and Drug Administration
Published: 1988-01-05

Substantially Equivalent

Syva Co.

FDA 510(k) clearance K874856 for EMIT CONVENIENCE PACK: PHENYTOIN ASSAY, Substantially Equivalent on 1988-01-05. Applicant: Syva Co.. Device class: 2.

Clearance details

Applicant: Syva Co.
Product code: Code DIP
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1987-11-25
Decision date: 1988-01-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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