K031490 is an FDA 510(k) clearance for the RUBELLACOL. This device is classified as a Latex Agglutination Assay, Rubella (Class II - Special Controls, product code LQN).
Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on July 16, 2003, 65 days after receiving the submission on May 12, 2003.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K031490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2003 |
| Decision Date | July 16, 2003 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LQN - Latex Agglutination Assay, Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |