K100179 is an FDA 510(k) clearance for the SPAPLUS. This device is classified as a Complement C3, Antigen, Antiserum, Control (Class II - Special Controls, product code CZW).
Submitted by The Binding Site Group , Ltd. (Los Angele, US). The FDA issued a Cleared decision on August 13, 2010, 204 days after receiving the submission on January 21, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K100179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2010 |
| Decision Date | August 13, 2010 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CZW — Complement C3, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |