K801456 is an FDA 510(k) clearance for the F/LS MCA APPLICATION SOFTWARE. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980, 101 days after receiving the submission on June 24, 1980.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K801456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1980 |
| Decision Date | October 03, 1980 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |