K896271 is an FDA 510(k) clearance for the QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL). This device is classified as a System, Test, Rheumatoid Factor (Class II - Special Controls, product code DHR).
Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on November 8, 1989, 9 days after receiving the submission on October 30, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775.
| 510(k) Number | K896271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 1989 |
| Decision Date | November 08, 1989 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DHR — System, Test, Rheumatoid Factor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |