The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Nichols Apo B Chemiluminescence Assay.
| Device ID | K925702 |
| 510k Number | K925702 |
| Device Name: | NICHOLS APO B CHEMILUMINESCENCE ASSAY |
| Classification | Apolipoproteins |
| Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Contact | Ramakrishnan |
| Correspondent | Ramakrishnan NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-12 |
| Decision Date | 1992-12-23 |