510(k) K011163— MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
Substantially EquivalentSyva Co., Dade Behring, Inc.
Clearance details
- Applicant
- Syva Co., Dade Behring, Inc.
- Product code
- Code JXN
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.