AMEDITECH DRUGSMARTCUP
FDA 510(k) clearance K053175 · decided 2005-12-08
Clearance details
- K-number
- K053175
- Device name
- AMEDITECH DRUGSMARTCUP
- Applicant
- Ameditech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-14
- Decision date
- 2005-12-08
- Days to decision
- 24 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 |
|---|---|---|
| Drug Check, Distributed by Express Diagnostics Intl Inc., 1550 Industrial Drive, Blue Eart recall (Z-3104-2011) | Express Diagnostics Int'l., Inc. | 2011-08-31 |
| DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue Ear recall (Z-2387-2011) | Express Diagnostics Int'l., Inc. | 2011-05-27 |