K972457 is an FDA 510(k) clearance for the MONOCOL/LEX-IM TEST. This device is classified as a System, Test, Infectious Mononucleosis (Class II - Special Controls, product code KTN).
Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on December 1, 1997, 153 days after receiving the submission on July 1, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5640.
| 510(k) Number | K972457 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1997 |
| Decision Date | December 01, 1997 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | KTN - System, Test, Infectious Mononucleosis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5640 |