The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Hematocrit And Metabolite Qualicheck.
| Device ID | K150226 |
| 510k Number | K150226 |
| Device Name: | Hematocrit And Metabolite QUALICHECK |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK |
| Contact | Mette Skytte Harpsoee |
| Correspondent | Mette Skytte Harpsoee RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-02 |
| Decision Date | 2015-05-13 |
| Summary: | summary |