The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Ck-mb And Ck-mb Calibrators On The Access Immunoassay Systems, Models 386371 And 386372.
| Device ID | K030012 |
| 510k Number | K030012 |
| Device Name: | CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 |
| Classification | Fluorometric Method, Cpk Or Isoenzymes |
| 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 | JHX |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-02 |
| Decision Date | 2003-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590232412 | K030012 | 000 |
| 15099590232368 | K030012 | 000 |