The following data is part of a premarket notification filed by Alba Bioscience Limited (doing Business As Quotient) 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 | BK080051 |
| 510k Number | BK080051 |
| 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 | ALBA Bioscience Limited (doing Business As Quotient) 21 Ellen's Glen Road liberton, Edinburgh Scotland, United Kingdom, EH17 7QT, UK |
| 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 | 2008-09-29 |
| Decision Date | 2009-04-08 |