Submission Details
| 510(k) Number | K130162 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 23, 2013 |
| Decision Date | March 01, 2013 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
LIQUID ASSAYED MULTIQUAL PREMIUM
Mar 2013
Decision
37d
Days
Class 1
Risk
About This 510(k) Submission
K130162 is an FDA 510(k) clearance for the LIQUID ASSAYED MULTIQUAL PREMIUM, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bio-Rad Laboratories (Irvine, US). The FDA issued a Cleared decision on March 1, 2013, 37 days after receiving the submission on January 23, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
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