KINETI COUNT 48 IMMUNOASSAY SYSTEM
Device Facts
| Record ID | K830365 |
|---|---|
| Device Name | KINETI COUNT 48 IMMUNOASSAY SYSTEM |
| Applicant | Medical & Scientific Designs, Inc. |
| Product Code | JJJ · Clinical Chemistry |
| Decision Date | Mar 10, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2320 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A beta or gamma counter for clinical use is a device intended to detect and count beta or gamma radiation emitted by clinical samples. Clinical samples are prepared by addition of a radioactive reagent to the sample. These measurements are useful in the diagnosis and treatment of various disorders.
