HDL CHOLESTEROL TEST KIT— 510(k) K801726
Substantially EquivalentMallinckrodt Critical Care
FDA 510(k) clearance K801726 for HDL CHOLESTEROL TEST KIT, Substantially Equivalent on 1980-09-09. Applicant: Mallinckrodt Critical Care. Device class: 1.
Clearance details
- Applicant
- Mallinckrodt Critical Care
- 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
- Mchenry, IL, US
Recent devices under product code LBS
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