K890041 is an FDA 510(k) clearance for the V-TREND TARGET IM TEST. This device is classified as a System, Test, Infectious Mononucleosis (Class II - Special Controls, product code KTN).
Submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on January 23, 1989, 18 days after receiving the submission on January 5, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5640.
| 510(k) Number | K890041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1989 |
| Decision Date | January 23, 1989 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | KTN — System, Test, Infectious Mononucleosis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5640 |