The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Automated Blood Grouping And Antibody Test Systems.
| Device ID | BK990043 |
| 510k Number | BK990043 |
| Device Name: | Automated Blood Grouping And Antibody Test Systems |
| Classification | System, Test, Automated Blood Grouping And Antibody |
| Applicant | Genetic Testing Institute 150 N. Patrick Blvd. Brookfield, WI 53045 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 | 1999-12-03 |
| Decision Date | 2000-10-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234500063 | BK990043 | 0 |