The following data is part of a premarket notification filed by Hemagen Diagnostics, Inc. with the FDA for Raichem Crp High Sensitivity Test System.
| Device ID | K021194 |
| 510k Number | K021194 |
| Device Name: | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Jose A Montanez |
| Correspondent | Jose A Montanez HEMAGEN DIAGNOSTICS, INC. 9033 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-15 |
| Decision Date | 2002-07-29 |