K900087 is an FDA 510(k) clearance for the GENESYS 6000 GAMMA COUNTER. This device is classified as a Counter (beta, Gamma) For Clinical Use (Class I - General Controls, product code JJJ).
Submitted by Laboratory Technologies, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 19, 1990, 195 days after receiving the submission on January 5, 1990.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2320.
| 510(k) Number | K900087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1990 |
| Decision Date | July 19, 1990 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JJJ — Counter (beta, Gamma) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2320 |