TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
FDA 510(k) clearance K032057 · decided 2003-08-21
Clearance details
- K-number
- K032057
- Device name
- TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
- Applicant
- Branan Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-07-02
- Decision date
- 2003-08-21
- Days to decision
- 50 days
- Clearance type
- Special
- Product code
- DIO
- Device class
- 2
- Regulation number
- 862.3250
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a scree recall (Z-1508-2014) | Branan Medical Corporation | 2014-04-24 |