The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Sero/tex Crp Test.
| Device ID | K821388 |
| 510k Number | K821388 |
| Device Name: | SERO/TEX CRP TEST |
| Classification | System, Test, C-reactive Protein |
| Applicant | TEXAS IMMUNOLOGY, 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 | 1982-05-10 |
| Decision Date | 1982-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816057021628 | K821388 | 000 |
| 00816057020348 | K821388 | 000 |
| 00816057020355 | K821388 | 000 |
| 00816057020362 | K821388 | 000 |
| 00816057020379 | K821388 | 000 |
| 00816057020386 | K821388 | 000 |
| 00816057020393 | K821388 | 000 |
| 00816057021260 | K821388 | 000 |
| 00816057021277 | K821388 | 000 |
| 00816057020331 | K821388 | 000 |