Submission Details
| 510(k) Number | K150300 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 06, 2015 |
| Decision Date | December 11, 2015 |
| Days to Decision | 308 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
Liquichek Cardiac Markers Plus Control LT
Dec 2015
Decision
308d
Days
Class 1
Risk
About This 510(k) Submission
K150300 is an FDA 510(k) clearance for the Liquichek Cardiac Markers Plus Control LT, 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 December 11, 2015, 308 days after receiving the submission on February 6, 2015. 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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