SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L— 510(k) K965240
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K965240 for SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L, Substantially Equivalent on 1997-03-10. Applicant: Beckman Instruments, Inc..
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Code JJE
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Adverse events under product code JJE
product code JJE- Death
- 6
- Injury
- 441
- Malfunction
- 25,011
- Other
- 1
- Total
- 25,459
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.