The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Folate Calibrators On The Access Immunoassay Systems Model A98033.
| Device ID | K111952 |
| 510k Number | K111952 |
| Device Name: | ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 |
| Classification | Calibrator, Secondary |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. MS R-275-B Chaska, MN 55318 -1084 |
| Contact | Kerrie S Oetter |
| Correspondent | Kerrie S Oetter BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. MS R-275-B Chaska, MN 55318 -1084 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-11 |
| Decision Date | 2011-08-19 |
| Summary: | summary |