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 |