The following data is part of a premarket notification filed by Medical & Scientific Designs, Inc. with the FDA for Kineti Count 48 Immunoassay System.
| Device ID | K830365 |
| 510k Number | K830365 |
| Device Name: | KINETI COUNT 48 IMMUNOASSAY SYSTEM |
| Classification | Counter (beta, Gamma) For Clinical Use |
| Applicant | MEDICAL & SCIENTIFIC DESIGNS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-04 |
| Decision Date | 1983-03-10 |