The following data is part of a premarket notification filed by Utak Laboratories, Inc. with the FDA for Serum Vancomycin Toxicology Control.
| Device ID | K862419 |
| 510k Number | K862419 |
| Device Name: | SERUM VANCOMYCIN TOXICOLOGY CONTROL |
| Classification | Drug Specific Control Materials |
| Applicant | UTAK LABORATORIES, INC. 26752 OAK AVE # 5 Canyon Country, CA 91351 |
| Contact | Lawrence B Plutchak |
| Correspondent | Lawrence B Plutchak UTAK LABORATORIES, INC. 26752 OAK AVE # 5 Canyon Country, CA 91351 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-25 |
| Decision Date | 1986-11-13 |