K050119 is an FDA 510(k) clearance for the PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT. This device is classified as a Immunochemical, Bence-jones Protein (Class II - Special Controls, product code JKM).
Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on May 6, 2005, 108 days after receiving the submission on January 18, 2005.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5150.
| 510(k) Number | K050119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 18, 2005 |
| Decision Date | May 06, 2005 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JKM — Immunochemical, Bence-jones Protein |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5150 |