K922417 is an FDA 510(k) clearance for the AL-ACID GLYCOPROTEIN RID KIT. This device is classified as a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I - General Controls, product code LKL).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on August 20, 1992, 91 days after receiving the submission on May 21, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5420.
| 510(k) Number | K922417 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1992 |
| Decision Date | August 20, 1992 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKL — Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5420 |