The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration Follow Fda En Español Search Fda Home Food Drugs Medical Devices .
| Device ID | BK920025 |
| 510k Number | BK920025 |
| Device Name: | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices |
| Classification | Kit, Cell Screening, Fetal |
| Applicant | Baxter Healthcare Corporation 1 Baxter Pkwy. Deerfield, IL 60015 |
| Product Code | MTI |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-28 |
| Decision Date | 1993-08-05 |