The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Dade Urine Chemistry Control, Level 1 & Level 2.
| Device ID | K933435 |
| 510k Number | K933435 |
| Device Name: | DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Rosetta Geffen |
| Correspondent | Rosetta Geffen BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-14 |
| Decision Date | 1993-09-24 |