The following data is part of a premarket notification filed by Fujirebio Diagnostics, Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.
Device ID | BK070030 |
510k Number | BK070030 |
Device Name: | Automated Blood Grouping And Antibody Test Systems |
Classification | System, Test, Automated Blood Grouping And Antibody |
Applicant | Fujirebio Diagnostics, Inc. 201 Great Valley Parkway Malvern, PA 19355 US |
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 | 2007-06-06 |
Decision Date | 2007-09-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850212007058 | BK070030 | 0 |
04987270227541 | BK070030 | 0 |