The following data is part of a premarket notification filed by Atomic Products Corp. with the FDA for Atomlab 100, Model 086-250 & 200 Model 086-270.
| Device ID | K884312 |
| 510k Number | K884312 |
| Device Name: | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 |
| Classification | Calibrator, Dose, Radionuclide |
| Applicant | ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
| Contact | Clyde Schlein |
| Correspondent | Clyde Schlein ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
| Product Code | KPT |
| CFR Regulation Number | 892.1360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-13 |
| Decision Date | 1989-02-16 |