The following data is part of a premarket notification filed by Research Diagnostics, Inc. with the FDA for Human Igg Subclasses Nephelometric Bna Kit.
| Device ID | K944876 |
| 510k Number | K944876 |
| Device Name: | HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT |
| Classification | Igg (fc Fragment Specific), Antigen, Antiserum, Control |
| Applicant | RESEARCH DIAGNOSTICS, INC. PLEASANT HILL RD. Flanders, NJ 07836 |
| Contact | Bret G Wien |
| Correspondent | Bret G Wien RESEARCH DIAGNOSTICS, INC. PLEASANT HILL RD. Flanders, NJ 07836 |
| Product Code | DAS |
| CFR Regulation Number | 866.5530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1994-12-15 |