The following data is part of a premarket notification filed by Tri-tech, Inc. with the FDA for Tri-tech Inc. Custom Blood Alcohol.
| Device ID | K922342 |
| 510k Number | K922342 |
| Device Name: | TRI-TECH INC. CUSTOM BLOOD ALCOHOL |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | TRI-TECH, INC. 5108 REVERE RD. Durham, NC 27713 |
| Contact | Wendie Walker |
| Correspondent | Wendie Walker TRI-TECH, INC. 5108 REVERE RD. Durham, NC 27713 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-19 |
| Decision Date | 1993-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869373000259 | K922342 | 000 |
| 00869373000211 | K922342 | 000 |