The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Tdm Plus Xl Enhanced Liq Drug Control I,ii,iii.
| Device ID | K904141 |
| 510k Number | K904141 |
| Device Name: | TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Donna L Anderson |
| Correspondent | Donna L Anderson MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1990-11-01 |