X-RAY ATTENUATING CREAM
FDA 510(k) clearance DEN120022 · decided 2013-05-09
Clearance details
- K-number
- DEN120022
- Device name
- X-RAY ATTENUATING CREAM
- Applicant
- Bloxr Corporation
- Decision
- Unknown
- Date received
- 2012-11-07
- Decision date
- 2013-05-09
- Days to decision
- 183 days
- Clearance type
- Direct
- Product code
- PDK
- Device class
- 2
- Regulation number
- 892.6510
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ULTRABLOX (K133684) | Bloxr Corporation | 2014-01-13 |
Recalls involving this device
No recalls on record reference this clearance.