MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
FDA 510(k) clearance K011163 · decided 2001-05-10
Clearance details
- K-number
- K011163
- Device name
- MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
- Applicant
- Syva Co., Dade Behring, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-16
- Decision date
- 2001-05-10
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- JXN
- Device class
- 2
- Regulation number
- 862.3700
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.