510(k) K991156
- Device
- Great Smokies Intestinal Permability Test System
- Applicant
- GREAT SMOKIES DIAGNOSTIC LABORATORY
- 510(k) number
- K991156
- Product code
- JOC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-05-28
- Date received
- 1999-04-07
- Regulation
- 862.1820
- Classification name
- Colorimetric, Xylose
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHEN BARRIE
- Address
- 63 Zillicoa St. Asheville NC US 28801 28801
FDA Registration Numbers#
- 1055886