The following data is part of a premarket notification filed by Medilab Corp. with the FDA for Immu-tec.
| Device ID | K841862 |
| 510k Number | K841862 |
| Device Name: | IMMU-TEC |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | MEDILAB CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-04 |
| Decision Date | 1984-06-13 |