510(k) K952246

TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT by Tri-Tech, Inc. — Product Code JXA

K952246 is an FDA 510(k) premarket notification submitted by Tri-Tech, Inc. for the device "TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT". The FDA issued a decision of Substantially Equivalent on June 20, 1995. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Tri-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1995
Date Received
May 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Urine
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type