K954392 is an FDA 510(k) clearance for the HYTEC AUTOIMMUNE KIT (SS-A). This device is classified as a Antinuclear Antibody, Antigen, Control (Class II - Special Controls, product code LKJ).
Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on December 26, 1995, 98 days after receiving the submission on September 19, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K954392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1995 |
| Decision Date | December 26, 1995 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |