PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
FDA 510(k) clearance K050119 · decided 2005-05-06
Clearance details
- K-number
- K050119
- Device name
- PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-18
- Decision date
- 2005-05-06
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- JKM
- Device class
- 2
- Regulation number
- 866.5150
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Beckman Coulter
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CAPILLARYS URINE (K080916) | Sebia | 2008-07-01 |
| CAPILLARYS URINE (PN 2012) (K070486) | Sebia, Inc. | 2007-12-21 |
| HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT (K972591) | Morax | 1998-03-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |