The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Paragon Cze 2000 Urine Protein Electrophoresis Kit And Urine Immunofixation By Subtraction Kit.
| Device ID | K050119 |
| 510k Number | K050119 |
| Device Name: | PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT |
| Classification | Immunochemical, Bence-jones Protein |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. P.O. BOX 8000, M/S W-515 Brea, CA 92822 -8000 |
| Contact | Kim Walker |
| Correspondent | Kim Walker BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. P.O. BOX 8000, M/S W-515 Brea, CA 92822 -8000 |
| Product Code | JKM |
| Subsequent Product Code | CFF |
| Subsequent Product Code | DEH |
| Subsequent Product Code | DFH |
| CFR Regulation Number | 866.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-18 |
| Decision Date | 2005-05-06 |
| Summary: | summary |