K920008 is an FDA 510(k) clearance for the IL TEST IMMUNOGLOBULIN M (IGM). This device is classified as a Method, Immunodiffusion, Immunoglobulins (g, A, M) (Class II - Special Controls, product code CGM).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 11, 1992, 69 days after receiving the submission on January 2, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5510.
| 510(k) Number | K920008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1992 |
| Decision Date | March 11, 1992 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | CGM — Method, Immunodiffusion, Immunoglobulins (g, A, M) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5510 |