The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for High Metabolite Qualicheck.
| Device ID | K130415 |
| 510k Number | K130415 |
| Device Name: | HIGH METABOLITE QUALICHECK |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | RADIOMETER MEDICAL APS AAKANDEVEJ 21 Broenshoej, DK Dk-2700 |
| Contact | Martin Gabler |
| Correspondent | Martin Gabler RADIOMETER MEDICAL APS AAKANDEVEJ 21 Broenshoej, DK Dk-2700 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-03-26 |
| Summary: | summary |