K842401 is an FDA 510(k) clearance for the CHEMISTRY CONSOLE. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I - General Controls, product code JQP).
Submitted by Biovation, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1984, 77 days after receiving the submission on June 19, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2100.
| 510(k) Number | K842401 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1984 |
| Decision Date | September 04, 1984 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JQP — Calculator/data Processing Module, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2100 |