ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270
Device Facts
| Record ID | K884312 |
|---|---|
| Device Name | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 |
| Applicant | Atomic Products Corp. |
| Product Code | KPT · Radiology |
| Decision Date | Feb 16, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1360 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.