K896433 is an FDA 510(k) clearance for the MODIFIED 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 November 29, 1989, 20 days after receiving the submission on November 9, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K896433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1989 |
| Decision Date | November 29, 1989 |
| Days to Decision | 20 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 |