The following data is part of a premarket notification filed by Future Diagnostics B.v. with the FDA for Future Diagnostics B.v. Stat-acth Kit.
| Device ID | K002638 |
| 510k Number | K002638 |
| Device Name: | FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT |
| Classification | Radioimmunoassay, Acth |
| 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 | CKG |
| CFR Regulation Number | 862.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-24 |
| Decision Date | 2001-01-17 |