KETOCHECKS
FDA 510(k) clearance K033114 · decided 2004-04-26
Clearance details
- K-number
- K033114
- Device name
- KETOCHECKS
- Applicant
- Neo Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-30
- Decision date
- 2004-04-26
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- JIN
- Device class
- 1
- Regulation number
- 862.1435
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.