K954893 is an FDA 510(k) clearance for the HYTEC AUTOMIMMUNE KIT (DS-DNA). This device is classified as a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II - Special Controls, product code LRM).
Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 20, 1996, 147 days after receiving the submission on October 25, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K954893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1995 |
| Decision Date | March 20, 1996 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LRM — Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |