CLINITEK ADVANTUS, MODEL 1420— 510(k) K063276
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K063276 for CLINITEK ADVANTUS, MODEL 1420, Substantially Equivalent on 2006-12-28. Applicant: Bayer Healthcare, LLC. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Product code JIL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1340
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norowood, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.