K790329 is an FDA 510(k) clearance for the A-GENT-HDL REAGENT. This device is classified as a Ldl & Vldl Precipitation, Hdl (Class I - General Controls, product code LBR).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 4, 1979, 47 days after receiving the submission on February 16, 1979.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K790329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1979 |
| Decision Date | April 04, 1979 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LBR — Ldl & Vldl Precipitation, Hdl |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |