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

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..

Clearance details

Applicant
Syva Co., Dade Behring, Inc.
Product code
Code KLS
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
San Jose, CA, US
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