K895996 is an FDA 510(k) clearance for the RHEUMELISA ASSAY FOR SM AUTOANTIBODIES. This device is classified as a Anti-sm Antibody, Antigen And Control (Class II - Special Controls, product code LKP).
Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on November 6, 1989, 24 days after receiving the submission on October 13, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K895996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1989 |
| Decision Date | November 06, 1989 |
| Days to Decision | 24 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LKP — Anti-sm Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |