K172613 is an FDA 510(k) clearance for the Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit. This device is classified as a Immunoglobulin G Kappa Heavy And Light Chain Combined (Class II - Special Controls, product code PCN).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on February 15, 2018, 168 days after receiving the submission on August 31, 2017.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510. Intended For The In-vitro Quantification Of Igg Kappa Concentration In Human Serum..
| 510(k) Number | K172613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2017 |
| Decision Date | February 15, 2018 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | PCN — Immunoglobulin G Kappa Heavy And Light Chain Combined |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |
| Definition | Intended For The In-vitro Quantification Of Igg Kappa Concentration In Human Serum. |