K945677 is an FDA 510(k) clearance for the IL682, CO-OXIMETER. This device is classified as a System, Hemoglobin, Automated (Class II - Special Controls, product code GKR).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 20, 1995, 336 days after receiving the submission on November 18, 1994.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5620.
| 510(k) Number | K945677 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 1994 |
| Decision Date | October 20, 1995 |
| Days to Decision | 336 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GKR — System, Hemoglobin, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5620 |