K970735 is an FDA 510(k) clearance for the BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL. This device is classified as a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I - General Controls, product code LBS).
Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on June 6, 1997, 108 days after receiving the submission on February 18, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K970735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 1997 |
| Decision Date | June 06, 1997 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |