KETOCHECKS— 510(k) K033114
Substantially EquivalentNeo Diagnostics, Inc.
FDA 510(k) clearance K033114 for KETOCHECKS, Substantially Equivalent on 2004-04-26. Applicant: Neo Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Neo Diagnostics, Inc.
- Product code
- Code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cypress, CA, US
Recent devices under product code JIN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.