The following data is part of a premarket notification filed by Alba Bioscience Limited (doing Business As Quotient) with the FDA for Stabilized Enzyme Solutions.
Device ID | BK140144 |
510k Number | BK140144 |
Device Name: | Stabilized Enzyme Solutions |
Classification | Solution, Stabilized Enzyme |
Applicant | ALBA Bioscience Limited (doing Business As Quotient) 21 Ellen's Glen Road liberton, Edinburgh Scotland, United Kingdom, EH17 7QT, UK |
Product Code | KSK |
CFR Regulation Number | 864.9400 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-02 |
Decision Date | 2014-09-17 |