Dade Chemistry Systems, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Dade Chemistry Systems, Inc. - FDA 510(k) Cleared Devices
13
Total
13
Cleared
0
Denied
Dade Chemistry Systems, Inc. has 13 FDA 510(k) cleared chemistry devices. Based in Newark, US.
Historical record: 13 cleared submissions from 1996 to 1997.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Dade Chemistry Systems, Inc.
13 devices
Cleared
Oct 20, 1997
TROPONIN (TROP) METHOD
Chemistry
25d
Cleared
Sep 29, 1997
PROSTATE SPECIFIC ANTIGEN CONTROL
Immunology
41d
Cleared
Sep 29, 1997
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
Immunology
41d
Cleared
Sep 18, 1997
PROSTATE SPECIFIC ANTIGEN METHOD
Immunology
30d
Cleared
Apr 28, 1997
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
Chemistry
31d
Cleared
Mar 10, 1997
HUMAN CHORIONIC GONADOTROPIN METHOD
Chemistry
35d
Cleared
Mar 03, 1997
MMB CALIBRATOR
Chemistry
33d
Cleared
Mar 03, 1997
THYROID STIMULATING HORMONE METHOD
Chemistry
28d
Cleared
Feb 20, 1997
HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
Chemistry
17d
Cleared
Feb 18, 1997
THYROID CALIBRATOR
Chemistry
15d
Cleared
Feb 14, 1997
MMB METHOD
Chemistry
16d
Cleared
Jan 24, 1997
FERR FLEX REAGENT CARTRIDGE
Chemistry
143d
Cleared
Dec 03, 1996
FERRITIN CALIBRATOR
Chemistry
91d