K790122 is an FDA 510(k) clearance for the RUBANON. This device is classified as a Antisera, Hai (including Hai Control), Rubella (Class II - Special Controls, product code GOK).
Submitted by Organon, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 15, 1979, 23 days after receiving the submission on January 23, 1979.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K790122 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 1979 |
| Decision Date | February 15, 1979 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GOK — Antisera, Hai (including Hai Control), Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |