K801438 is an FDA 510(k) clearance for the CENTRIFICHEM SYSTEM MANAGER. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I - General Controls, product code JQP).
Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980, 39 days after receiving the submission on June 19, 1980.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2100.
| 510(k) Number | K801438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1980 |
| Decision Date | July 28, 1980 |
| Days to Decision | 39 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 |