The following data is part of a premarket notification filed by Bay Area Hema. Onco. Clinic. & Res. L with the FDA for Thrombo-screen Platelet Adhesion.
| Device ID | K771678 |
| 510k Number | K771678 |
| Device Name: | THROMBO-SCREEN PLATELET ADHESION |
| Classification | Study, Platelet Adhesive |
| Applicant | BAY AREA HEMA. ONCO. CLINIC. & RES. L 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBZ |
| CFR Regulation Number | 864.6650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-02 |
| Decision Date | 1977-11-22 |