The following data is part of a premarket notification filed by Bio-rad with the FDA for Quantigen T & B Cell Assay.
| Device ID | K831053 |
| 510k Number | K831053 |
| Device Name: | QUANTIGEN T & B CELL ASSAY |
| Classification | Assay, T Lymphocyte Surface Marker |
| Applicant | BIO-RAD 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-01 |
| Decision Date | 1983-08-08 |