K852589 is an FDA 510(k) clearance for the TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT. This device is classified as a Igg, Antigen, Antiserum, Control (Class II - Special Controls, product code DEW).
Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on July 15, 1985, 27 days after receiving the submission on June 18, 1985.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K852589 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1985 |
| Decision Date | July 15, 1985 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DEW — Igg, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |