K882194 is an FDA 510(k) clearance for the GEMINII GAMMA COUNTER. This device is classified as a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I - General Controls, product code JJE).
Submitted by Laboratory Technologies, Inc. (Schaumburg, US). The FDA issued a Cleared decision on August 4, 1988, 71 days after receiving the submission on May 25, 1988.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2160.
| 510(k) Number | K882194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 1988 |
| Decision Date | August 04, 1988 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2160 |