The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric C-reactive Protein Assay R..
| Device ID | K811617 |
| 510k Number | K811617 |
| Device Name: | QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R. |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | KALLESTAD LABORATORIES, INC. 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 | 1981-06-08 |
| Decision Date | 1981-06-25 |