K905144 is an FDA 510(k) clearance for the ECLIPSE ICA GLUCOSE. This device is classified as a Hexokinase, Glucose (Class II - Special Controls, product code CFR).
Submitted by Biotope, Inc. (Redmond, US). The FDA issued a Cleared decision on January 4, 1991, 50 days after receiving the submission on November 15, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K905144 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1990 |
| Decision Date | January 04, 1991 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CFR — Hexokinase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |