K831903 is an FDA 510(k) clearance for the FLUORESCEIN CONJUGATED IMMUNOGLOBULIN. This device is classified as a Lambda, Fitc, Antigen, Antiserum, Control (Class II - Special Controls, product code DES).
Submitted by Dako Corp. (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 35 days after receiving the submission on June 14, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K831903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1983 |
| Decision Date | July 19, 1983 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DES — Lambda, Fitc, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |