Submission Details
| 510(k) Number | K133960 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 24, 2013 |
| Decision Date | January 22, 2014 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL
Jan 2014
Decision
29d
Days
Class 1
Risk
About This 510(k) Submission
K133960 is an FDA 510(k) clearance for the LYPOCHEK SPECIALTY IMMUNOASSAY CONTROL, 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 January 22, 2014, 29 days after receiving the submission on December 24, 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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