K954897 is an FDA 510(k) clearance for the HYTEC AUTOIMMUNE KITS (RNP). This device is classified as a Anti-rnp Antibody, Antigen And Control (Class II - Special Controls, product code LKO).
Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 22, 1996, 185 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 | K954897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1995 |
| Decision Date | March 22, 1996 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKO — Anti-rnp Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |