GENSTRIP TEST STRIP MODEL 100-201
FDA 510(k) clearance K103542 · decided 2012-11-30
Clearance details
- K-number
- K103542
- Device name
- GENSTRIP TEST STRIP MODEL 100-201
- Applicant
- Shasta Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-12-02
- Decision date
- 2012-11-30
- Days to decision
- 729 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.