ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY— 510(k) K050632
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K050632 for ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY, Substantially Equivalent on 2005-05-26. Applicant: Bayer Healthcare, LLC. Device class: 1.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Code LBS
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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