MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229— 510(k) K011163
Substantially EquivalentSyva Co., Dade Behring, Inc.
FDA 510(k) clearance K011163 for MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229, 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 JXN
- Device class
- Class 2
- Regulation
- 21 CFR 862.3700
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
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