K882740 is an FDA 510(k) clearance for the ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY. This device is classified as a Antinuclear Antibody, Antigen, Control (Class II - Special Controls, product code LKJ).
Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on September 22, 1988, 83 days after receiving the submission on July 1, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K882740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 1988 |
| Decision Date | September 22, 1988 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |