K902568 is an FDA 510(k) clearance for the REFLOTRON HDL CHOLESTEROL TEST TABS. This device is classified as a Ldl & Vldl Precipitation, Hdl (Class I - General Controls, product code LBR).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 9, 1990, 59 days after receiving the submission on June 11, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K902568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1990 |
| Decision Date | August 09, 1990 |
| Days to Decision | 59 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 |