Baxter Diagnostics, Inc. - FDA 510(k) Cleared Devices
72
Total
72
Cleared
0
Denied
FDA 510(k) Regulatory Record - Baxter Diagnostics, Inc. Chemistry ✕
14 devices
Cleared
Apr 11, 1995
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
Chemistry
67d
Cleared
Nov 22, 1994
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY
Chemistry
497d
Cleared
Oct 28, 1993
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
Chemistry
134d
Cleared
Oct 28, 1993
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3
Chemistry
106d
Cleared
Oct 22, 1993
STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY
Chemistry
98d
Cleared
Oct 08, 1993
STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY
Chemistry
73d
Cleared
Sep 24, 1993
DADE URINE CHEMISTRY CONTROL, LEVEL 1 & LEVEL 2
Chemistry
72d
Cleared
Aug 26, 1993
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
Chemistry
44d
Cleared
Jan 05, 1993
DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III
Chemistry
35d
Cleared
Oct 26, 1992
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
Chemistry
75d
Cleared
Oct 19, 1992
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
Chemistry
168d
Cleared
Aug 26, 1992
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
Chemistry
40d
Cleared
Jul 07, 1992
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
Chemistry
146d
Cleared
Oct 11, 1991
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
Chemistry
22d