The following data is part of a premarket notification filed by Alba Bioscience Limited (doing Business As Quotient) with the FDA for Kit, Quality Control For Blood Banking Reagents.
| Device ID | BK080027 |
| 510k Number | BK080027 |
| Device Name: | Kit, Quality Control For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | ALBA Bioscience Limited (doing Business As Quotient) 21 Ellen's Glen Road liberton, Edinburgh Scotland, United Kingdom, EH17 7QT, UK |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-09 |
| Decision Date | 2008-07-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060242471513 | BK080027 | 0 |