K822381 is an FDA 510(k) clearance for the SYVA LAB PROCESSOR 6000. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I - General Controls, product code JQP).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1982, 18 days after receiving the submission on August 9, 1982.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2100.
| 510(k) Number | K822381 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1982 |
| Decision Date | August 27, 1982 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JQP — Calculator/data Processing Module, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2100 |