K121045 is an FDA 510(k) clearance for the HUMAN ALBUMIN CSF KIT. This device is classified as a Albumin, Antigen, Antiserum, Control (Class II - Special Controls, product code DCF).
Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on June 19, 2013, 439 days after receiving the submission on April 6, 2012.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5040.
| 510(k) Number | K121045 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2012 |
| Decision Date | June 19, 2013 |
| Days to Decision | 439 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DCF — Albumin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5040 |