SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1— 510(k) K983709
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K983709 for SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1, Substantially Equivalent on 1998-10-28. Applicant: Beckman Coulter, Inc.. Device class: 1.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code DIF
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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More clearances from Beckman Coulter, Inc.
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