CHOLESTEROL, UNIVERSAL ET— 510(k) K896073
Substantially EquivalentEnzyme Technology, Inc.
FDA 510(k) clearance K896073 for CHOLESTEROL, UNIVERSAL ET, Substantially Equivalent on 1989-12-12. Applicant: Enzyme Technology, Inc.. Device class: 1.
Clearance details
- Applicant
- Enzyme Technology, 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
- Nashua, NH, US
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