TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
FDA 510(k) clearance K973784 · decided 1997-12-03
Clearance details
- K-number
- K973784
- Device name
- TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS
- Applicant
- Biosite Incorporated
- Decision
- Substantially Equivalent
- Date received
- 1997-10-03
- Decision date
- 1997-12-03
- Days to decision
- 61 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 |
| Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay u recall (Z-0521-2012) | Alere San Diego | 2012-01-11 |
| Triage Drugs of Abuse Panel, Model Number: 95000. Is an immunoassay test kit used for the recall (Z-1088-2009) | Biosite Inc | 2009-03-17 |