IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS— 510(k) K864409

Name: FDA 510(k) clearance K864409
Creator: U.S. Food and Drug Administration
Published: 1986-12-22

Substantially Equivalent

Sclavo, Inc.

FDA 510(k) clearance K864409 for IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS, Substantially Equivalent on 1986-12-22. Applicant: Sclavo, Inc.. Device class: 2.

Clearance details

Applicant: Sclavo, Inc.
Product code: Code LER
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1986-11-10
Decision date: 1986-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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