K893419 is an FDA 510(k) clearance for the COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM). This device is classified as a Igg, Antigen, Antiserum, Control (Class II - Special Controls, product code DEW).
Submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on August 3, 1989, 93 days after receiving the submission on May 2, 1989.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K893419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 1989 |
| Decision Date | August 03, 1989 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | DEW — Igg, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |