K961024 is an FDA 510(k) clearance for the BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB. This device is classified as a System, Test, Infectious Mononucleosis (Class II - Special Controls, product code KTN).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on February 4, 1997, 327 days after receiving the submission on March 14, 1996.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5640.
| 510(k) Number | K961024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1996 |
| Decision Date | February 04, 1997 |
| Days to Decision | 327 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 |