The following data is part of a premarket notification filed by Kenlor Industries, Inc. with the FDA for Kenlor Therapeutic Drug Monitoring (tdm) Control.
| Device ID | K903338 |
| 510k Number | K903338 |
| Device Name: | KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | KENLOR INDUSTRIES, INC. 9582 HAMLITON AVE. SUITE 251 Huntington Beach, CA 92646 |
| Contact | Kamales Som |
| Correspondent | Kamales Som KENLOR INDUSTRIES, INC. 9582 HAMLITON AVE. SUITE 251 Huntington Beach, CA 92646 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-25 |
| Decision Date | 1990-09-07 |