The following data is part of a premarket notification filed by Immucor Gti Diagnostics, Inc. with the FDA for Platelet Antibody Test.
| Device ID | BK140163 |
| 510k Number | BK140163 |
| Device Name: | Platelet Antibody Test |
| Classification | Test, Platelet Antibody |
| Applicant | Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha, WI 53186 |
| 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 | 2014-08-01 |
| Decision Date | 2015-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234500674 | BK140163 | 0 |
| 10888234500643 | BK140163 | 0 |
| 10888234500582 | BK140163 | 0 |
| 10888234500544 | BK140163 | 0 |
| 10888234500254 | BK140163 | 0 |