AMEDITECH IMMUTEST MILTI-DRUG SCREEN
FDA 510(k) clearance K113046 · decided 2011-11-10
Clearance details
- K-number
- K113046
- Device name
- AMEDITECH IMMUTEST MILTI-DRUG SCREEN
- Applicant
- Ameditech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-13
- Decision date
- 2011-11-10
- Days to decision
- 28 days
- Clearance type
- Special
- 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 |
|---|---|---|
| ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen recall (Z-0071-2015) | Ameditech Inc | 2014-10-16 |
| ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Scre recall (Z-0072-2015) | Ameditech Inc | 2014-10-16 |
| ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Scr recall (Z-0073-2015) | Ameditech Inc | 2014-10-16 |