The following data is part of a premarket notification filed by Diagnostic Grifols, S. A. with the FDA for Automated Blood Grouping And Antibody Test Systems.
Device ID | BK190379 |
510k Number | BK190379 |
Device Name: | Automated Blood Grouping And Antibody Test Systems |
Classification | System, Test, Automated Blood Grouping And Antibody |
Applicant | Diagnostic Grifols, S. A. passeig Fluvial, 24 barcelona Parets Del Valles, 08150, SP |
Product Code | KSZ |
CFR Regulation Number | 864.9175 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-07-31 |
Decision Date | 2019-10-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08437014205619 | BK190379 | 0 |