K905145 is an FDA 510(k) clearance for the ECLIPSE ICA CHOLESTEROL. This device is classified as a Enzymatic Esterase--oxidase, Cholesterol (Class I - General Controls, product code CHH).
Submitted by Biotope, Inc. (Redmond, US). The FDA issued a Cleared decision on February 26, 1991, 103 days after receiving the submission on November 15, 1990.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1175.
| 510(k) Number | K905145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 1990 |
| Decision Date | February 26, 1991 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHH — Enzymatic Esterase--oxidase, Cholesterol |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1175 |