PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT— 510(k) K050119
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K050119 for PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT, Substantially Equivalent on 2005-05-06. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code JKM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5150
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
Recent devices under product code JKM
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