Submission Details
| 510(k) Number | K123798 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 10, 2012 |
| Decision Date | January 09, 2013 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
Jan 2013
Decision
30d
Days
Class 1
Risk
About This 510(k) Submission
K123798 is an FDA 510(k) clearance for the LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on January 9, 2013, 30 days after receiving the submission on December 10, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
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