K161854 is an FDA 510(k) clearance for the Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS. 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. (Edgbaston, GB). The FDA issued a Cleared decision on October 4, 2016, 90 days after receiving the submission on July 6, 2016.
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 | K161854 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 2016 |
| Decision Date | October 04, 2016 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| 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. |