The following data is part of a premarket notification filed by Diagast with the FDA for Quality Control Kits For Blood Banking Reagents.
Device ID | BK160084 |
510k Number | BK160084 |
Device Name: | Quality Control Kits For Blood Banking Reagents |
Classification | Kit, Quality Control For Blood Banking Reagents |
Applicant | DIAGAST parc Eurasanté 251, Avenue Eugéne Avinée Loos Cedex, 59374, FR |
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 | 2016-08-19 |
Decision Date | 2018-02-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
23661562105438 | BK160084 | 0 |