K883004 is an FDA 510(k) clearance for the MONO-PLUS(TM). This device is classified as a System, Test, Infectious Mononucleosis (Class II - Special Controls, product code KTN).
Submitted by Wampole Laboratories (Cranbury, US). The FDA issued a Cleared decision on August 4, 1988, 17 days after receiving the submission on July 18, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5640.
| 510(k) Number | K883004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1988 |
| Decision Date | August 04, 1988 |
| Days to Decision | 17 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 |