K820427 is an FDA 510(k) clearance for the IL 8060 DATA MANAGEMENT SYSTEM. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I - General Controls, product code JQP).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on March 11, 1982, 22 days after receiving the submission on February 17, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2100.
| 510(k) Number | K820427 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1982 |
| Decision Date | March 11, 1982 |
| Days to Decision | 22 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 |