The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Platelet Antibody Test.
| Device ID | BK980005 |
| 510k Number | BK980005 |
| Device Name: | Platelet Antibody Test |
| Classification | Test, Platelet Antibody |
| Applicant | Genetic Testing Institute 150 N. Patrick Blvd. Brookfield, WI 53045 US |
| Product Code | MYP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-03 |
| Decision Date | 1999-04-23 |