LFS LIPOGEL ASSAY KIT— 510(k) K960785
Substantially EquivalentZaxis, Inc.
FDA 510(k) clearance K960785 for LFS LIPOGEL ASSAY KIT, Substantially Equivalent on 1996-09-03. Applicant: Zaxis, Inc.. Device class: 1.
Clearance details
- Applicant
- Zaxis, Inc.
- Product code
- Code JHO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hudson, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.