The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Sero/tex Le Test.
| Device ID | K821385 |
| 510k Number | K821385 |
| Device Name: | SERO/TEX LE TEST |
| Classification | System, Test, Systemic Lupus Erythematosus |
| Applicant | TEXAS IMMUNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DHC |
| CFR Regulation Number | 866.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-10 |
| Decision Date | 1982-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816057021604 | K821385 | 000 |
| 00816057020256 | K821385 | 000 |
| 00816057020249 | K821385 | 000 |
| 00816057020232 | K821385 | 000 |
| 00816057020225 | K821385 | 000 |
| 00816057020218 | K821385 | 000 |
| 00816057020201 | K821385 | 000 |
| 00816057020195 | K821385 | 000 |