EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY— 510(k) K850712

Name: FDA 510(k) clearance K850712
Creator: U.S. Food and Drug Administration
Published: 1985-03-20

Substantially Equivalent

Syva Co.

FDA 510(k) clearance K850712 for EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY, Substantially Equivalent on 1985-03-20. 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: 1985-02-22
Decision date: 1985-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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