COULTER CHOLESTEROL REAGENT— 510(k) K897162
Substantially EquivalentCoulter Electronics, Inc.
FDA 510(k) clearance K897162 for COULTER CHOLESTEROL REAGENT, Substantially Equivalent on 1990-03-29. Applicant: Coulter Electronics, Inc.. Device class: 1.
Clearance details
- Applicant
- Coulter Electronics, Inc.
- Product code
- Code CHH
- Device class
- Class 1
- Regulation
- 21 CFR 862.1175
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hialeah, FL, US
Recent devices under product code CHH
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