ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
FDA 510(k) clearance K993031 · decided 2000-01-27
Clearance details
- K-number
- K993031
- Device name
- ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54
- 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
- DLZ
- Device class
- 2
- Regulation number
- 862.3660
- 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 |
|---|---|---|
| Clinical Chemistry Phenobarbital, list number 1E08 recall (Z-1118-2013) | Abbott Laboratories, Inc | 2013-04-15 |
| Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Divisio recall (Z-0454-2007) | Abbott Laboratories Inc. | 2007-01-09 |