The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for C1-inhibitor Microtiter Assay Device.
| Device ID | K003747 |
| 510k Number | K003747 |
| Device Name: | C1-INHIBITOR MICROTITER ASSAY DEVICE |
| Classification | Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control |
| Applicant | BAXTER HEALTHCARE CORP. 550 NORTH BRAND BLVD. Glendale, CA 91023 |
| Contact | Arlene Vidor |
| Correspondent | Arlene Vidor BAXTER HEALTHCARE CORP. 550 NORTH BRAND BLVD. Glendale, CA 91023 |
| Product Code | DBA |
| CFR Regulation Number | 866.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-04 |
| Decision Date | 2001-03-19 |