K813379 is an FDA 510(k) clearance for the RADIONUCLIDE DOSE CALIBRATOR. This device is classified as a Calibrator, Dose, Radionuclide (Class II - Special Controls, product code KPT).
Submitted by Medi Nuclear Corp., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982, 52 days after receiving the submission on December 1, 1981.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1360.
| 510(k) Number | K813379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1981 |
| Decision Date | January 22, 1982 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | KPT — Calibrator, Dose, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1360 |