The following data is part of a premarket notification filed by Nobel Scientific Industries, Inc. with the FDA for Nsi Astra Tm Albumin Reagent Kit Nsi Item # 7926.
| Device ID | K854718 |
| 510k Number | K854718 |
| Device Name: | NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | NOBEL SCIENTIFIC INDUSTRIES, INC. 1423 LESLIE AVE. Alexandria, VA 22301 |
| Contact | Donald F Dwyer |
| Correspondent | Donald F Dwyer NOBEL SCIENTIFIC INDUSTRIES, INC. 1423 LESLIE AVE. Alexandria, VA 22301 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-22 |
| Decision Date | 1985-12-19 |