K894975 is an FDA 510(k) clearance for the IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST. This device is classified as a System, Test, Infectious Mononucleosis (Class II - Special Controls, product code KTN).
Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 13, 1989, 37 days after receiving the submission on August 7, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5640.
| 510(k) Number | K894975 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 1989 |
| Decision Date | September 13, 1989 |
| Days to Decision | 37 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 |