CEDIA THEOPHYLLINE ASSAY— 510(k) K961462

Name: FDA 510(k) clearance K961462
Creator: U.S. Food and Drug Administration
Published: 1996-06-27

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K961462 for CEDIA THEOPHYLLINE ASSAY, Substantially Equivalent on 1996-06-27. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1996-04-17
Decision date: 1996-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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