K950382 is an FDA 510(k) clearance for the APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT. This device is classified as a Turbidimetric Method, Lipoproteins (Class I - General Controls, product code JHN).
Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on September 15, 1995, 227 days after receiving the submission on January 31, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K950382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1995 |
| Decision Date | September 15, 1995 |
| Days to Decision | 227 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JHN — Turbidimetric Method, Lipoproteins |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |