The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Ck-mb On The Access Immunoassay Analyzer.
| Device ID | K000716 |
| 510k Number | K000716 |
| Device Name: | ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Angela M Byland |
| Correspondent | Angela M Byland BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-03 |
| Decision Date | 2000-03-20 |