K100455 is an FDA 510(k) clearance for the SPAPLUS ANALYZER. This device is classified as a Complement C4, Antigen, Antiserum, Control (Class II - Special Controls, product code DBI).
Submitted by The Binding Site (Los Angeles, US). The FDA issued a Cleared decision on September 3, 2010, 198 days after receiving the submission on February 17, 2010.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5240.
| 510(k) Number | K100455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2010 |
| Decision Date | September 03, 2010 |
| Days to Decision | 198 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DBI — Complement C4, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5240 |