510(k) K922342
K922342 is an FDA 510(k) premarket notification submitted by Tri-Tech, Inc. for the device "TRI-TECH INC. CUSTOM BLOOD ALCOHOL". The FDA issued a decision of Substantially Equivalent (kit, denovo) on August 27, 1993. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Tri-Tech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- August 27, 1993
- Date Received
- May 19, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device Class
- Class II
- Regulation Number
- 862.1675
- Review Panel
- CH
- Submission Type