SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS— 510(k) K071280
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K071280 for SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS, Substantially Equivalent on 2007-06-01. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code CGX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Brea, CA, US
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