MONITORX LASERX THEOPHYLLINE REAGENT SET— 510(k) K870277

Name: FDA 510(k) clearance K870277
Creator: U.S. Food and Drug Administration
Published: 1987-02-18

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K870277 for MONITORX LASERX THEOPHYLLINE REAGENT SET, Substantially Equivalent on 1987-02-18. Applicant: American Monitor Corp.. Device class: 2.

Clearance details

Applicant: American Monitor Corp.
Product code: Code LGS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1987-01-27
Decision date: 1987-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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