Dade Intl., Inc. - FDA 510(k) Cleared Devices
30
Total
30
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dade Intl., Inc. Chemistry ✕
16 devices
Cleared
Nov 06, 1997
DADE TRU-LIQUID CARDIAC CONTROL
Chemistry
17d
Cleared
Oct 20, 1997
CARDIAC TROPONIN-I (TROP) CALIBRATOR
Chemistry
25d
Cleared
Aug 15, 1997
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
Chemistry
21d
Cleared
Jul 07, 1997
DADE TRU-LIQUID BILIRUBIN CONTROL
Chemistry
18d
Cleared
Jun 04, 1997
PARAMAX CHOLESTEROL REAGENT
Chemistry
196d
Cleared
Apr 14, 1997
DADE INDIRECT IMT SYSTEM WITH TCO2 ELECTRODE
Chemistry
76d
Cleared
Mar 28, 1997
PARAMAX TRIGLYCERID REAGENT
Chemistry
148d
Cleared
Feb 10, 1997
TROPONIN-I TEST SYSTEM
Chemistry
68d
Cleared
Nov 22, 1996
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT
Chemistry
8d
Cleared
Aug 15, 1996
ACA PLUS FT4 CALIBRATOR
Chemistry
44d
Cleared
Aug 15, 1996
ACA PLUS FREE THYROXINE(FT4) METHOD
Chemistry
44d
Cleared
Apr 26, 1996
DADE MONI-TROL CANDIDATE PRODUCT COMBINATIONS
Chemistry
106d
Cleared
Jul 17, 1995
STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB...
Chemistry
63d
Cleared
Jul 13, 1995
DADE STRATUS TROPONIN-I CONTROL
Chemistry
80d
Cleared
Jul 13, 1995
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS...
Chemistry
80d
Cleared
Jun 19, 1995
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT
Chemistry
102d