K895600 is an FDA 510(k) clearance for the HUMAN (IGG) SUBCLASS (EIA) KIT. This device is classified as a Igg (fc Fragment Specific), Antigen, Antiserum, Control (Class I - General Controls, product code DAS).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on November 8, 1989, 51 days after receiving the submission on September 18, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5530.
| 510(k) Number | K895600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1989 |
| Decision Date | November 08, 1989 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DAS — Igg (fc Fragment Specific), Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5530 |