DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
FDA 510(k) clearance K081378 · decided 2009-01-14
Clearance details
- K-number
- K081378
- Device name
- DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
- Applicant
- Thermo Fisher Scientific
- Decision
- Substantially Equivalent
- Date received
- 2008-05-16
- Decision date
- 2009-01-14
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- DJR
- Device class
- 2
- Regulation number
- 862.3620
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Fremont Blvd., CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.