LIPOPROTEIN CALIBRATOR— 510(k) K031682
Substantially EquivalentBayer Healthcare, LLC
FDA 510(k) clearance K031682 for LIPOPROTEIN CALIBRATOR, Substantially Equivalent on 2003-06-25. Applicant: Bayer Healthcare, LLC. Device class: 2.
Clearance details
- Applicant
- Bayer Healthcare, LLC
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Tarrytown, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.