The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Accutni+3 Reagent And Access Accutn1+3 Calibrators For Use On The Access 2 Immunoassay System.
| Device ID | K121214 |
| 510k Number | K121214 |
| Device Name: | ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Kerrie Oetter |
| Correspondent | Kerrie Oetter BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | MMI |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-23 |
| Decision Date | 2013-06-14 |
| Summary: | summary |