ONLINE DAT PROPOXYPHENE PLUS
FDA 510(k) clearance K043303 · decided 2005-03-11
Clearance details
- K-number
- K043303
- Device name
- ONLINE DAT PROPOXYPHENE PLUS
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-30
- Decision date
- 2005-03-11
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- JXN
- Device class
- 2
- Regulation number
- 862.3700
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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