K923087 is an FDA 510(k) clearance for the IL TEST APOLIPOPROTEIN A1. This device is classified as a Apolipoproteins (Class I - General Controls, product code MSJ).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on October 26, 1992, 123 days after receiving the submission on June 25, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K923087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1992 |
| Decision Date | October 26, 1992 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | MSJ — Apolipoproteins |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |