SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR— 510(k) K013076
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K013076 for SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR, Substantially Equivalent on 2001-12-12. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code LEH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3950
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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