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 | BK060062 |
| 510k Number | BK060062 |
| 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 | 2006-12-01 |
| Decision Date | 2007-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850212007041 | BK060062 | 0 |
| 04987270226964 | BK060062 | 0 |