K863868 is an FDA 510(k) clearance for the IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT. This device is classified as a Alpha-1-antichymotrypsin, Antigen, Antiserum, Control (Class II - Special Controls, product code DFF).
Submitted by Cooper Biomedical, Inc. (Malvern, US). The FDA issued a Cleared decision on February 13, 1987, 133 days after receiving the submission on October 3, 1986.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5080.
| 510(k) Number | K863868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 1986 |
| Decision Date | February 13, 1987 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DFF — Alpha-1-antichymotrypsin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5080 |