The following data is part of a premarket notification filed by Kallestad Laboratories, Inc. with the FDA for Quantimetric 2 C-reactive Protein Reag..
Device ID | K821984 |
510k Number | K821984 |
Device Name: | QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG. |
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 | 1982-07-06 |
Decision Date | 1982-07-22 |