510(k) K912888
K912888 is an FDA 510(k) premarket notification submitted by Dynagen, Inc. for the device "URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL". The FDA issued a decision of Substantially Equivalent on February 24, 1992. The device falls under product code MIG (Strip, Test Isoniazid), a Class U device. Dynagen, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1992
- Date Received
- July 1, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strip, Test Isoniazid
- Device Class
- Class U
- Regulation Number
- Review Panel
- TX
- Submission Type