The following data is part of a premarket notification filed by Utak Lab, Inc. with the FDA for Tri-level Whole Blood Lead Toxicology Control.
| Device ID | K943422 |
| 510k Number | K943422 |
| Device Name: | TRI-LEVEL WHOLE BLOOD LEAD TOXICOLOGY CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | UTAK LAB, INC. 25020 AVE TIBBITTS Valencia, CA 91355 |
| Contact | Lawrence Plutchak |
| Correspondent | Lawrence Plutchak UTAK LAB, INC. 25020 AVE TIBBITTS Valencia, CA 91355 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-15 |
| Decision Date | 1994-11-02 |