The following data is part of a premarket notification filed by Immucor Gti Diagnostics, Inc. with the FDA for Pf4 Enhanced Assay.
| Device ID | K201570 |
| 510k Number | K201570 |
| Device Name: | PF4 Enhanced Assay |
| Classification | Platelet Factor 4 Radioimmunoassay |
| Applicant | Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha, WI 53186 |
| Contact | Allison Stray |
| Correspondent | Allison Stray Immucor GTI Diagnostics, Inc. 20925 Crossroads Circle Waukesha, WI 53186 |
| Product Code | LCO |
| CFR Regulation Number | 864.7695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-11 |
| Decision Date | 2020-09-11 |