Submission Details
| 510(k) Number | K121608 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 01, 2012 |
| Decision Date | February 15, 2013 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS
Feb 2013
Decision
259d
Days
Class 2
Risk
About This 510(k) Submission
K121608 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS 25-OH VITAMIN D TOTAL REAGENT PACK, VITAMIN D TOTAL CALIBRATORS, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 15, 2013, 259 days after receiving the submission on June 1, 2012. 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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