Submission Details
| 510(k) Number | K070546 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 2007 |
| Decision Date | April 02, 2007 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
LYPHOCHEK DIABETES CONTROL
Apr 2007
Decision
35d
Days
Class 2
Risk
About This 510(k) Submission
K070546 is an FDA 510(k) clearance for the LYPHOCHEK DIABETES CONTROL, a Control, Hemoglobin (Class II — Special Controls, product code GGM), submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on April 2, 2007, 35 days after receiving the submission on February 26, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.8625.
Device Classification
| Product Code | GGM — Control, Hemoglobin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.8625 |
Manufacturer
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