Submission Details
| 510(k) Number | K041478 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 03, 2004 |
| Decision Date | October 28, 2004 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR
Oct 2004
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K041478 is an FDA 510(k) clearance for the BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR, a Glucose Oxidase, Glucose (Class II — Special Controls, product code CGA), submitted by Becton Dickinson (Franklin Lakes, US). The FDA issued a Cleared decision on October 28, 2004, 147 days after receiving the submission on June 3, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.
Device Classification
| Product Code | CGA — Glucose Oxidase, Glucose |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1345 |
Manufacturer
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