SYNCHRON SYSTEMS CREATININE REAGENT— 510(k) K071283
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K071283 for SYNCHRON SYSTEMS CREATININE REAGENT, 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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