K821060 is an FDA 510(k) clearance for the FLUORO-CEP..
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1982, 68 days after receiving the submission on April 15, 1982.
This device falls under the Chemistry FDA review panel.
| 510(k) Number | K821060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1982 |
| Decision Date | June 22, 1982 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | — |
| Device Class | — |