The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Autocheck6+.
| Device ID | K051928 |
| 510k Number | K051928 |
| Device Name: | AUTOCHECK6+ |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Lene M Marnaes |
| Correspondent | Lene M Marnaes RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-10-12 |
| Summary: | summary |