K832258 is an FDA 510(k) clearance for the GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC. This device is classified as a Igg, Antigen, Antiserum, Control (Class II - Special Controls, product code DEW).
Submitted by Gelco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983, 123 days after receiving the submission on June 30, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K832258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 1983 |
| Decision Date | October 31, 1983 |
| Days to Decision | 123 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 |