The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Paragon Cze 2000 Capillary Electrophoresis System And Buffer-100.
| Device ID | K002799 |
| 510k Number | K002799 |
| Device Name: | PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | CFF |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-08 |
| Decision Date | 2000-10-05 |