K924197 is an FDA 510(k) clearance for the ZORBA(TM) IGG REMOVAL REAGENT. This device is classified as a Igg, Antigen, Antiserum, Control (Class II - Special Controls, product code DEW).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on December 15, 1992, 117 days after receiving the submission on August 20, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K924197 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1992 |
| Decision Date | December 15, 1992 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DEW — Igg, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |