510(k) K890134
K890134 is an FDA 510(k) premarket notification submitted by Evergreen Scientific, Inc. for the device "FTK FECAL TRANSPORT KIT". The FDA issued a decision of Substantially Equivalent on April 21, 1989. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Evergreen Scientific, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1989
- Date Received
- January 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Specimen Collection
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type