K874678 is an FDA 510(k) clearance for the I.M.N. LATEX. This device is classified as a System, Test, Infectious Mononucleosis (Class II - Special Controls, product code KTN).
Submitted by Biokit USA, Inc. (Barcelona, Spain, US). The FDA issued a Cleared decision on December 14, 1987, 31 days after receiving the submission on November 13, 1987.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5640.
| 510(k) Number | K874678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1987 |
| Decision Date | December 14, 1987 |
| Days to Decision | 31 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 |