Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack — Diasorin Molecular, LLC (510(k) K173498)
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack — Diasorin Molecular, LLC (510(k) K173498) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack; Applicant: Diasorin Molecular, LLC; Clearance t
| Device name | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack |
|---|---|
| Applicant | Diasorin Molecular, LLC |
| Clearance track | 510(k) |
| Submission number | K173498 |
| Decision | Substantially Equivalent |
| Decision date | 2018-08-13 |
| Date received | 2017-11-13 |
| Product code | OZZ |
| Device class | 2 |
| Medical specialty | Microbiology |
| Applicant location | CA, US |
| Source | openFDA device |
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