GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
FDA 510(k) clearance K991156 · decided 1999-05-28
Clearance details
- K-number
- K991156
- Device name
- GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
- Applicant
- Great Smokies Diagnostic Laboratory
- Decision
- Substantially Equivalent
- Date received
- 1999-04-07
- Decision date
- 1999-05-28
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- JOC
- Device class
- 1
- Regulation number
- 862.1820
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Asheville, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.