K914993 is an FDA 510(k) clearance for the IL TEST(TM) TRANSFERRIN (TRF). This device is classified as a Transferrin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDG).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 17, 1992, 71 days after receiving the submission on November 7, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5880.
| 510(k) Number | K914993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1991 |
| Decision Date | January 17, 1992 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DDG — Transferrin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5880 |