The following data is part of a premarket notification filed by Laboratory Technologies, Inc. with the FDA for Genesys Gamma Counter.
| Device ID | K851689 |
| 510k Number | K851689 |
| Device Name: | GENESYS GAMMA COUNTER |
| Classification | Counter (beta, Gamma) For Clinical Use |
| Applicant | LABORATORY TECHNOLOGIES, INC. 4N645 MOHICAN Elburn, IL 60119 |
| Contact | Oestelin |
| Correspondent | Oestelin LABORATORY TECHNOLOGIES, INC. 4N645 MOHICAN Elburn, IL 60119 |
| Product Code | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-26 |
| Decision Date | 1985-08-07 |