ETI-MAX 3000— 510(k) K052794
Substantially EquivalentDiaSorin, Inc.
FDA 510(k) clearance K052794 for ETI-MAX 3000, Substantially Equivalent on 2006-03-31. Applicant: DiaSorin, Inc.. Device class: 1.
Clearance details
- Applicant
- DiaSorin, Inc.
- Product code
- Code JJF
- Device class
- Class 1
- Regulation
- 21 CFR 862.2170
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stillwater, MN, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.