510(k) K991156
K991156 is an FDA 510(k) premarket notification submitted by Great Smokies Diagnostic Laboratory for the device "GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on May 28, 1999. The device falls under product code JOC (Colorimetric, Xylose), a Class I device regulated under 21 CFR 862.1820.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 1999
- Date Received
- April 7, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetric, Xylose
- Device Class
- Class I
- Regulation Number
- 862.1820
- Review Panel
- CH
- Submission Type