COULTER HDL - CHOLESTEROL REAGENT— 510(k) K902174
Substantially EquivalentCoulter Corp.
FDA 510(k) clearance K902174 for COULTER HDL - CHOLESTEROL REAGENT, Substantially Equivalent on 1990-07-31. Applicant: Coulter Corp.. Device class: 1.
Clearance details
- Applicant
- Coulter Corp.
- 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
- Hialeah, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.