IMMPULSE PHENYTOIN ASSAY REAGENT— 510(k) K862554

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K862554 for IMMPULSE PHENYTOIN ASSAY REAGENT, Substantially Equivalent on 1986-07-16. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code LGR
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1986-07-03
Decision date: 1986-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.