K811740 is an FDA 510(k) clearance for the KALLESTAD'S ENDOPLATE FACTOR B TEST. This device is classified as a Factor B, Antigen, Antiserum, Control (Class II - Special Controls, product code JZH).
Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1981, 27 days after receiving the submission on June 19, 1981.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5320.
| 510(k) Number | K811740 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1981 |
| Decision Date | July 16, 1981 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZH — Factor B, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5320 |