DRI ECSTASY ENZYME IMMUNOASSAY — Microgenics Corp. (510(k) K012110)
DRI ECSTASY ENZYME IMMUNOASSAY — Microgenics Corp. (510(k) K012110) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: DRI ECSTASY ENZYME IMMUNOASSAY; Applicant: Microgenics Corp.; Clearance track: 510(k).
| Device name | DRI ECSTASY ENZYME IMMUNOASSAY |
|---|---|
| Applicant | Microgenics Corp. |
| Clearance track | 510(k) |
| Submission number | K012110 |
| Decision | Substantially Equivalent |
| Decision date | 2001-08-27 |
| Date received | 2001-07-06 |
| Product code | DKZ |
| Device class | 2 |
| Medical specialty | Clinical Toxicology |
| Applicant location | CA, US |
| Source | openFDA device |
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$1999/mo
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