The following data is part of a premarket notification filed by Genetic Testing Institute, Inc. (gti) with the FDA for Platelet Antibody Test.
| Device ID | BK960059 |
| 510k Number | BK960059 |
| Device Name: | Platelet Antibody Test |
| Classification | Test, Platelet Antibody |
| Applicant | Genetic Testing Institute, Inc. (GTI) 20925 Crossroads Circle sutie 200 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 | 1996-07-08 |
| Decision Date | 1998-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234500728 | BK960059 | 0 |
| 10888234500360 | BK960059 | 0 |
| 10888234500377 | BK960059 | 0 |
| 10888234500407 | BK960059 | 0 |
| 10888234500445 | BK960059 | 0 |
| 10888234500476 | BK960059 | 0 |
| 10888234500490 | BK960059 | 0 |
| 10888234500537 | BK960059 | 0 |
| 10888234500551 | BK960059 | 0 |
| 10888234500568 | BK960059 | 0 |
| 10888234500575 | BK960059 | 0 |
| 10888234500599 | BK960059 | 0 |
| 10888234500636 | BK960059 | 0 |
| 10888234500650 | BK960059 | 0 |
| 10888234500247 | BK960059 | 0 |