TRIAGE TOX DRUG SCREEN
FDA 510(k) clearance K043242 · decided 2005-02-28
Clearance details
- K-number
- K043242
- Device name
- TRIAGE TOX DRUG SCREEN
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2004-11-23
- Decision date
- 2005-02-28
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- LDP
- Device class
- 2
- Regulation number
- 862.3030
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fl recall (Z-2460-2012) | Alere San Diego, Inc. | 2012-09-26 |