K902636 is an FDA 510(k) clearance for the LIPOGEN RHEUMELISA DSDNA ASSAY. This device is classified as a Punch, Surgical (Class I - General Controls, product code LRY).
Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on June 28, 1990, 14 days after receiving the submission on June 14, 1990.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K902636 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1990 |
| Decision Date | June 28, 1990 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LRY — Punch, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |