The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Sero/tex Mono Test.
| Device ID | K821386 |
| 510k Number | K821386 |
| Device Name: | SERO/TEX MONO TEST |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | TEXAS IMMUNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| 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 |
|---|---|---|
| 00816057021611 | K821386 | 000 |
| 00816057020324 | K821386 | 000 |
| 00816057020317 | K821386 | 000 |
| 00816057020300 | K821386 | 000 |
| 00816057020294 | K821386 | 000 |
| 00816057020287 | K821386 | 000 |
| 00816057020270 | K821386 | 000 |
| 00816057020263 | K821386 | 000 |
| 20885380114363 | K821386 | 000 |