IMMPULSE PHENOBARBITAL ASSAY REAGENTS— 510(k) K862528

Name: FDA 510(k) clearance K862528
Creator: U.S. Food and Drug Administration
Published: 1986-07-16

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K862528 for IMMPULSE PHENOBARBITAL ASSAY REAGENTS, Substantially Equivalent on 1986-07-16. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code LGQ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1986-07-02
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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