ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
FDA 510(k) clearance K993026 · decided 2000-01-27
Clearance details
- K-number
- K993026
- Device name
- ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-09
- Decision date
- 2000-01-27
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- DIP
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of recall (Z-2059-2008) | Abbott Laboratories Inc. | 2008-09-16 |