The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Cea Reagents On The Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209.
| Device ID | K981985 |
| 510k Number | K981985 |
| Device Name: | ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 |
| Classification | System, Test, Carcinoembryonic Antigen |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Ellen M Voss |
| Correspondent | Ellen M Voss BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | DHX |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-05 |
| Decision Date | 1998-09-24 |
| Summary: | summary |