K883353 is an FDA 510(k) clearance for the IQ HDL CHOLESTEROL. This device is classified as a Ldl & Vldl Precipitation, Hdl (Class I - General Controls, product code LBR).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 13, 1988, 35 days after receiving the submission on August 9, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K883353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 1988 |
| Decision Date | September 13, 1988 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LBR — Ldl & Vldl Precipitation, Hdl |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |