The following data is part of a premarket notification filed by Beckman with the FDA for Modification To Access Cea Reagents For Use On The Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206.
| Device ID | K991707 |
| 510k Number | K991707 |
| Device Name: | MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | BECKMAN 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Angela Byland |
| Correspondent | Angela Byland BECKMAN 1000 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-19 |
| Decision Date | 1999-06-01 |
| Summary: | summary |