THE TRIAGE II
FDA 510(k) clearance K924476 · decided 1993-01-22
Clearance details
- K-number
- K924476
- Device name
- THE TRIAGE II
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 1992-09-03
- Decision date
- 1993-01-22
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- DKZ
- Device class
- 2
- Regulation number
- 862.3100
- 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 Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abu recall (Z-1130-2012) | Alere San Diego | 2012-03-01 |