The following data is part of a premarket notification filed by Immunostics Co., Inc. with the FDA for Immuno-crp.
| Device ID | K834390 |
| 510k Number | K834390 |
| Device Name: | IMMUNO-CRP |
| Classification | System, Test, C-reactive Protein |
| Applicant | IMMUNOSTICS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DCN |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-14 |
| Decision Date | 1984-02-03 |