The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Dade Tru-liquid Moni-trol Chemistry Control Levels 1, Mid, 2, And S (assayed).
| Device ID | K001758 |
| 510k Number | K001758 |
| Device Name: | DADE TRU-LIQUID MONI-TROL CHEMISTRY CONTROL LEVELS 1, MID, 2, AND S (ASSAYED) |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO RD. Camarillo, CA 93012 |
| Contact | Scot D Kinghorn |
| Correspondent | Scot D Kinghorn MEDICAL ANALYSIS SYSTEMS, INC. 5300 ADOLFO 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 | 2000-06-09 |
| Decision Date | 2000-07-05 |