MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229— 510(k) K011166

Name: FDA 510(k) clearance K011166
Creator: U.S. Food and Drug Administration
Published: 2001-05-10

Substantially Equivalent

Syva Co., Dade Behring, Inc.

FDA 510(k) clearance K011166 for MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229, Substantially Equivalent on 2001-05-10. Applicant: Syva Co., Dade Behring, Inc.. Device class: 2.

Clearance details

Applicant: Syva Co., Dade Behring, Inc.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 2001-04-16
Decision date: 2001-05-10
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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