ROCHE ACETAMINOPHEN
FDA 510(k) clearance K013757 · decided 2002-01-08
Clearance details
- K-number
- K013757
- Device name
- ROCHE ACETAMINOPHEN
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-13
- Decision date
- 2002-01-08
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LDP
- Device class
- 2
- Regulation number
- 862.3030
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Dia recall (Z-1679-2011) | Roche Diagnostics Operations, Inc. | 2011-03-16 |
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|---|---|---|
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