SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I— 510(k) K983209
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K983209 for SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I, Substantially Equivalent on 1998-11-04. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code DKB
- Device class
- Class 2
- Regulation
- 21 CFR 862.3200
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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