The following data is part of a premarket notification filed by Nobel Scientific Industries, Inc. with the FDA for Nsi Lysing-d Reagent -4000 Ml.
| Device ID | K850944 |
| 510k Number | K850944 |
| Device Name: | NSI LYSING-D REAGENT -4000 ML |
| Classification | Products, Red-cell Lysing Products |
| Applicant | NOBEL SCIENTIFIC INDUSTRIES, INC. 1423 LESLIE AVE. Alexandria, VA 22301 |
| Contact | Dale E Thompson |
| Correspondent | Dale E Thompson NOBEL SCIENTIFIC INDUSTRIES, INC. 1423 LESLIE AVE. Alexandria, VA 22301 |
| Product Code | GGK |
| CFR Regulation Number | 864.8540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-07 |
| Decision Date | 1985-03-29 |