The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Sero/tex Rf Test.
| Device ID | K821319 |
| 510k Number | K821319 |
| Device Name: | SERO/TEX RF TEST |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | TEXAS IMMUNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-04 |
| Decision Date | 1982-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816057021642 | K821319 | 000 |
| 00816057020508 | K821319 | 000 |
| 00816057020492 | K821319 | 000 |
| 00816057020485 | K821319 | 000 |
| 00816057020478 | K821319 | 000 |
| 00816057020461 | K821319 | 000 |
| 20885380020220 | K821319 | 000 |
| 20885380020213 | K821319 | 000 |