The following data is part of a premarket notification filed by Tri-tech, Inc. with the FDA for Tri-techin. Custom Blood And/or Urine Transport Kit.
| Device ID | K952246 |
| 510k Number | K952246 |
| Device Name: | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT |
| Classification | Kit, Screening, Urine |
| Applicant | TRI-TECH, INC. 4019 EXECUTIVE PARK BLVD.,S.E. Southport, NC 28461 |
| Contact | Wendie H Walker |
| Correspondent | Wendie H Walker TRI-TECH, INC. 4019 EXECUTIVE PARK BLVD.,S.E. Southport, NC 28461 |
| Product Code | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-12 |
| Decision Date | 1995-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869373000235 | K952246 | 000 |
| 00869373000228 | K952246 | 000 |