Atomlab 100, Model 086-250 & 200 Model 086-270
by Atomic Products Corp. 510(k)
Active
510(k) K884312
Overview
The Atomlab 100, Model 086-250 and 200 Model 086-270 are radionuclide dose calibrators. These devices are designed to measure the activity of radionuclides used in medical applications.
These devices are regulated under FDA 510(k) clearance. They are classified as Class 2 medical devices under regulation number 892.1360.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884312 | Date16 Feb 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KPT
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1360
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Atomic Products Corp.
Questions
What is the primary function of the Atomlab 100 and 200?
These devices are radionuclide dose calibrators specifically engineered to measure the activity of radionuclides used in various medical applications. They provide precise measurements necessary for clinical procedures involving radioactive materials.
What regulatory classification do these dose calibrators hold?
The Atomlab 100 and 200 are classified as Class 2 medical devices under regulation number 892.1360. They have received FDA 510(k) clearance, which indicates they have been found substantially equivalent to legally marketed predicate devices.
Which specific models are included in this product line?
This product line includes the Atomlab 100, identified by model number 086-250, and the Atomlab 200, identified by model number 086-270. Both models are designed for the measurement of radionuclide activity within a radiology setting.