K840217 is an FDA 510(k) clearance for the CHOLESTEROL AQUEOUS STANDARD. This device is classified as a Calibrator, Primary (Class II - Special Controls, product code JIS).
Submitted by Preventive Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984, 64 days after receiving the submission on January 19, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K840217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1984 |
| Decision Date | March 23, 1984 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIS — Calibrator, Primary |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |