The following data is part of a premarket notification filed by Tri-tech, Inc. with the FDA for Stat/pb Reagent.
| Device ID | K843839 |
| 510k Number | K843839 |
| Device Name: | STAT/PB REAGENT |
| Classification | Lead, Atomic Absorption |
| Applicant | TRI-TECH, INC. 5120 REVERE ROAD Durham , NC 27713 - |
| Contact | Jay W Walker |
| Correspondent | Jay W Walker TRI-TECH, INC. 5120 REVERE ROAD Durham , NC 27713 - |
| Product Code | DOF |
| CFR Regulation Number | 862.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-01 |
| Decision Date | 1985-01-03 |