K090296 is an FDA 510(k) clearance for the ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336. This device is classified as a Calibrator, Dose, Radionuclide (Class II - Special Controls, product code KPT).
Submitted by Biodex Medical Systems, Inc. (Shirley, US). The FDA issued a Cleared decision on February 19, 2009, 13 days after receiving the submission on February 6, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1360.
| 510(k) Number | K090296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2009 |
| Decision Date | February 19, 2009 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KPT — Calibrator, Dose, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1360 |