GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
FDA 510(k) clearance K110899 · decided 2012-02-01
Clearance details
- K-number
- K110899
- Device name
- GOLD STANDARD DIAGNOSTICS H. PYLORI ELISA IGA TEST KIT
- Applicant
- Gold Standard Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2011-03-30
- Decision date
- 2012-02-01
- Days to decision
- 308 days
- Clearance type
- Traditional
- Product code
- LYR
- Device class
- 1
- Regulation number
- 866.3110
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Davis, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.