HDL CHOLESTEROL PLUS— 510(k) K000568
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K000568 for HDL CHOLESTEROL PLUS, Substantially Equivalent on 2000-08-04. Applicant: Roche Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code LBT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code LBT
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- K972015 — HYDRAGEL 7,15,30, CHOL-HDL KIT
- K904035 — REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM
- K894366 — REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187
- K882368 — REP HDL ELECTROPHORESIS METHOD
More clearances from Roche Diagnostics Corp.
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