K923079 is an FDA 510(k) clearance for the IL TEST CALIBRATION SET APO A1B. This device is classified as a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II - Special Controls, product code DFC).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on February 5, 1993, 225 days after receiving the submission on June 25, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5600.
| 510(k) Number | K923079 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1992 |
| Decision Date | February 05, 1993 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5600 |