K861881 is an FDA 510(k) clearance for the RUBALEX (REVISED VERSION). This device is classified as a Latex Agglutination Assay, Rubella (Class II — Special Controls, product code LQN).
Submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on June 4, 1986, 27 days after receiving the submission on May 8, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K861881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1986 |
| Decision Date | June 04, 1986 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LQN — Latex Agglutination Assay, Rubella |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3510 |