K943205 is an FDA 510(k) clearance for the HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION). This device is classified as a Igg (fc Fragment Specific), Antigen, Antiserum, Control (Class I - General Controls, product code DAS).
Submitted by Research Diagnostics, Inc. (Flanders, US). The FDA issued a Cleared decision on September 7, 1994, 64 days after receiving the submission on July 5, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5530.
| 510(k) Number | K943205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1994 |
| Decision Date | September 07, 1994 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DAS — Igg (fc Fragment Specific), Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5530 |