SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS— 510(k) K993023
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K993023 for SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS, Substantially Equivalent on 1999-11-26. Applicant: Beckman Coulter, Inc.. Device class: 1.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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