K954890 is an FDA 510(k) clearance for the HYTEC AUTOMMUNE KIT (ENA). This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II - Special Controls, product code LLL).
Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on December 26, 1995, 62 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 | K954890 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 1995 |
| Decision Date | December 26, 1995 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |