Submission Details
| 510(k) Number | K180577 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 05, 2018 |
| Decision Date | June 22, 2018 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
BioPlex 2200 25-OH Vitamin D Kit
Jun 2018
Decision
109d
Days
Class 2
Risk
About This 510(k) Submission
K180577 is an FDA 510(k) clearance for the BioPlex 2200 25-OH Vitamin D Kit, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on June 22, 2018, 109 days after receiving the submission on March 5, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.
Device Classification
| Product Code | MRG — System, Test, Vitamin D |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1825 |
Manufacturer
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