K003747 is an FDA 510(k) clearance for the C1-INHIBITOR MICROTITER ASSAY DEVICE. This device is classified as a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II - Special Controls, product code DBA).
Submitted by Baxter Healthcare Corp (Glendale, US). The FDA issued a Cleared decision on March 19, 2001, 105 days after receiving the submission on December 4, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5250.
| 510(k) Number | K003747 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2000 |
| Decision Date | March 19, 2001 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DBA — Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5250 |