The following data is part of a premarket notification filed by Future Diagnostics B.v. with the FDA for Future Diagnostics B.v. Stat-intraoperative Intact Pth Kit.
| Device ID | K000471 |
| 510k Number | K000471 |
| Device Name: | FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | FUTURE DIAGNOSTICS B.V. 4079 MT. BARNARD San Diego, CA 92111 |
| Contact | Dave D Smith |
| Correspondent | Dave D Smith FUTURE DIAGNOSTICS B.V. 4079 MT. BARNARD San Diego, CA 92111 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-14 |
| Decision Date | 2000-04-11 |