K940422 is an FDA 510(k) clearance for the IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY ANALYZER. This device is classified as a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II - Special Controls, product code DFZ).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on May 27, 1994, 128 days after receiving the submission on January 19, 1994.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K940422 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1994 |
| Decision Date | May 27, 1994 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DFZ — Igg (gamma Chain Specific), Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |