The following data is part of a premarket notification filed by Laboratory Technologies, Inc. with the FDA for Geminii Gamma Counter.
| Device ID | K882194 |
| 510k Number | K882194 |
| Device Name: | GEMINII GAMMA COUNTER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | LABORATORY TECHNOLOGIES, INC. 1517 S. WRIGHT Schaumburg, IL 60193 |
| Contact | Richard J Schmidt |
| Correspondent | Richard J Schmidt LABORATORY TECHNOLOGIES, INC. 1517 S. WRIGHT Schaumburg, IL 60193 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-25 |
| Decision Date | 1988-08-04 |