The following data is part of a premarket notification filed by Nobel Scientific Industries, Inc. with the FDA for Nsi Reagent System For Ortho Elt-8 Hema.
| Device ID | K801346 |
| 510k Number | K801346 |
| Device Name: | NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA |
| Classification | Diluent, Blood Cell |
| Applicant | NOBEL SCIENTIFIC INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GIF |
| CFR Regulation Number | 864.8200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-06-09 |
| Decision Date | 1980-08-12 |