The following data is part of a premarket notification filed by Genetic Testing Institute with the FDA for Platelet Antibody Test.
| Device ID | BK930032 |
| 510k Number | BK930032 |
| Device Name: | Platelet Antibody Test |
| Classification | Test, Platelet Antibody |
| Applicant | Genetic Testing Institute 1701 W. Wisconsin Avenue, Suite 429 Milwaukee, WI 53233 |
| 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 | 1993-10-26 |
| Decision Date | 1994-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234500612 | BK930032 | 0 |
| 10888234500605 | BK930032 | 0 |
| 10888234500513 | BK930032 | 0 |
| 10888234500506 | BK930032 | 0 |
| 10888234500469 | BK930032 | 0 |
| 10888234500452 | BK930032 | 0 |
| 10888234500223 | BK930032 | 0 |
| 10888234500216 | BK930032 | 0 |