The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Accutni And Accutni Calibrators On The Access Immunoassay System # 33340, 33345.
| Device ID | K010429 |
| 510k Number | K010429 |
| Device Name: | ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Brent Taber |
| Correspondent | Brent Taber BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-13 |
| Decision Date | 2001-06-05 |