Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer— 510(k) DEN190042
UnknownBaxter Healthcare Corporation
FDA 510(k) clearance DEN190042 for Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer, Unknown on 2020-08-28. Applicant: Baxter Healthcare Corporation. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- Product code
- Code QAX
- Device class
- Class 2
- Regulation
- 21 CFR 876.5862
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Round Lake, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.