IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS— 510(k) K865102

Name: FDA 510(k) clearance K865102
Creator: U.S. Food and Drug Administration
Published: 1987-01-13

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K865102 for IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS, Substantially Equivalent on 1987-01-13. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code LES
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1986-12-24
Decision date: 1987-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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