K821852 is an FDA 510(k) clearance for the DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT..
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1982, 9 days after receiving the submission on June 23, 1982.
This device falls under the Chemistry FDA review panel.
| 510(k) Number | K821852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1982 |
| Decision Date | July 02, 1982 |
| Days to Decision | 9 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | — |
| Device Class | — |