FDA 510(k) Applications Submitted by DADE CHEMISTRY SYSTEMS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970336 |
01/29/1997 |
MMB CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
| K970343 |
01/29/1997 |
MMB METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
| K970389 |
02/03/1997 |
THYROID CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
| K971141 |
03/28/1997 |
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM |
DADE CHEMISTRY SYSTEMS, INC. |
| K963493 |
09/03/1996 |
FERRITIN CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
| K963498 |
09/03/1996 |
FERR FLEX REAGENT CARTRIDGE |
DADE CHEMISTRY SYSTEMS, INC. |
| K970387 |
02/03/1997 |
HUMAN CHORIONIC GONADOTROPIN METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
| K970393 |
02/03/1997 |
THYROID STIMULATING HORMONE METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
| K970396 |
02/03/1997 |
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
| K973099 |
08/19/1997 |
PROSTATE SPECIFIC ANTIGEN CONTROL |
DADE CHEMISTRY SYSTEMS, INC. |
| K973100 |
08/19/1997 |
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR |
DADE CHEMISTRY SYSTEMS, INC. |
| K973101 |
08/19/1997 |
PROSTATE SPECIFIC ANTIGEN METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
| K973650 |
09/25/1997 |
TROPONIN (TROP) METHOD |
DADE CHEMISTRY SYSTEMS, INC. |
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