K012901 is an FDA 510(k) clearance for the COLOR-MONOGEN. This device is classified as a System, Test, Infectious Mononucleosis (Class II - Special Controls, product code KTN).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 27, 2001, 29 days after receiving the submission on August 29, 2001.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5640.
| 510(k) Number | K012901 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2001 |
| Decision Date | September 27, 2001 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | KTN — System, Test, Infectious Mononucleosis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5640 |