SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
FDA 510(k) clearance K955644 · decided 1996-02-16
Clearance details
- K-number
- K955644
- Device name
- SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-12
- Decision date
- 1996-02-16
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- KLT
- Device class
- 2
- Regulation number
- 862.3645
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: K recall (Z-1173-2012) | Beckman Coulter Inc. | 2012-03-06 |
| Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subseq recall (Z-1174-2012) | Beckman Coulter Inc. | 2012-03-06 |
| SYNCHRON Gentamicin (GEN) Reagent GEN reagent, when used in conjunction with SYNCHRON LX S recall (Z-2437-2010) | Beckman Coulter Inc. | 2010-09-20 |
| Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, recall (Z-0935-04) | Beckman Coulter Inc | 2004-07-20 |