TRIAGE TOX DRUG SCREEN, MODEL 94400
FDA 510(k) clearance K060791 · decided 2006-06-22
Clearance details
- K-number
- K060791
- Device name
- TRIAGE TOX DRUG SCREEN, MODEL 94400
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2006-03-23
- Decision date
- 2006-06-22
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- DJR
- Device class
- 2
- Regulation number
- 862.3620
- 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 |
|---|---|---|
| Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013 recall (Z-1214-2014) | Alere San Diego, Inc. | 2014-03-17 |
| Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a recall (Z-0029-2013) | Alere San Diego, Inc. | 2012-10-10 |
| 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 |
| Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen recall (Z-2039-2012) | Alere San Diego, Inc. | 2012-07-19 |
| Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouc recall (Z-1446-2012) | Alere San Diego dba Biosite Innovacon Hemosense Inc | 2012-04-20 |