HDL REAGENT— 510(k) K800996
Substantially EquivalentGilford Diagnostics
FDA 510(k) clearance K800996 for HDL REAGENT, Substantially Equivalent on 1980-05-14. Applicant: Gilford Diagnostics. Device class: 1.
Clearance details
- Applicant
- Gilford Diagnostics
- Product code
- Code LBR
- 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 LBR
view all- K143691 — LDLC3 LDL-Cholesterol Gen.3
- K072523 — DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS
- K050823 — DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
- K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
- K012593 — VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
More clearances from Gilford Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.