K083223 is an FDA 510(k) clearance for the RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01. This device is classified as a Glucose Dehydrogenase, Glucose (Class II - Special Controls, product code LFR).
Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on April 16, 2009, 164 days after receiving the submission on November 3, 2008.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1345.
| 510(k) Number | K083223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2008 |
| Decision Date | April 16, 2009 |
| Days to Decision | 164 days |
| Submission Type | Special |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LFR — Glucose Dehydrogenase, Glucose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1345 |