The following data is part of a premarket notification filed by Tri-tech, Inc. with the FDA for Tri-tech Inc., Evacuated Blood Collection Tube, Gray Stopper.
| Device ID | K971111 |
| 510k Number | K971111 |
| Device Name: | TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | TRI-TECH, INC. 4019 EXECUTIVE PARK BLVD.,S.E. Southport, NC 28461 |
| Contact | Wendie Walker |
| Correspondent | Wendie Walker TRI-TECH, INC. 4019 EXECUTIVE PARK BLVD.,S.E. Southport, NC 28461 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-26 |
| Decision Date | 1997-06-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10869373000201 | K971111 | 000 |