The following data is part of a De Novo classification by Bloxr Corporation with the FDA for X-ray Attenuating Cream.
| DeNovo ID | DEN120022 |
| Device Name: | X-RAY ATTENUATING CREAM |
| Classification | Cream For X-ray Attenuation |
| Applicant | BLOXR CORPORATION 960 West Levoy Drive suite 100 Salt Lake City, UT 84123 |
| Contact | Rai Chowdhary |
| Product Code | PDK |
| CFR Regulation Number | 892.6510 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K123422 |
| Review Advisory Board | Radiology |
| Classification Advisory | Radiology |
| Type | Direct |
| Date Received | 2012-11-07 |
| Decision Date | 2013-05-09 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |