K893755 is an FDA 510(k) clearance for the RUBAGEN. This device is classified as a Latex Agglutination Assay, Rubella (Class II - Special Controls, product code LQN).
Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on August 21, 1989, 94 days after receiving the submission on May 19, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K893755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 1989 |
| Decision Date | August 21, 1989 |
| Days to Decision | 94 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 |