K030215 is an FDA 510(k) clearance for the BIORAPID MONONUCLEOSIS. 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 February 24, 2003, 34 days after receiving the submission on January 21, 2003.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5640.
| 510(k) Number | K030215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2003 |
| Decision Date | February 24, 2003 |
| Days to Decision | 34 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 |