SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
FDA 510(k) clearance K973696 · decided 1997-11-24
Clearance details
- K-number
- K973696
- Device name
- SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-09-26
- Decision date
- 1997-11-24
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- LCP
- Device class
- 2
- Regulation number
- 864.7470
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vigil Lipid Control Serum, Levels 1, 2 and 4 for LDL Cholesterol Reagent Part No.: 469905 recall (Z-1155-04) | Beckman Coulter Inc | 2004-07-23 |
| Vigil Lipid Control, Levels 1,2,3 and 4 for ApoB Reagent. recall (Z-1156-04) | Beckman Coulter Inc | 2004-07-23 |