Baxter Diagnostics, Inc. - FDA 510(k) Cleared Devices
72
Total
72
Cleared
0
Denied
72 devices
Cleared
Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGG EIA
Microbiology
112d
Cleared
Sep 02, 1992
BARTELS RUBEOLA IGM EIA
Microbiology
112d
Cleared
Sep 02, 1992
BARTELS LYME DISEASE IGM EIA
Microbiology
98d
Cleared
Sep 02, 1992
BARTELS TOXOPLASMA IGM EIA
Microbiology
98d
Cleared
Sep 02, 1992
BARTELS TOXOPLASMA IGG EIA
Microbiology
98d
Cleared
Aug 26, 1992
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
Chemistry
40d
Cleared
Jul 27, 1992
DADE RECOMBOPLASTIN S
Hematology
131d
Cleared
Jul 21, 1992
STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY
Immunology
76d
Cleared
Jul 15, 1992
DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL
Immunology
56d
Cleared
Jul 07, 1992
DADE URINE CHEMISTRY CONTROL LEVELS I AND II
Chemistry
146d
Cleared
Jun 04, 1992
DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA
Hematology
99d
Cleared
May 22, 1992
APOLIPOPROTEIN TEST SYSTEM
Immunology
79d
Cleared
May 11, 1992
DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA
Hematology
161d
Cleared
Jan 15, 1992
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
Hematology
82d
Cleared
Oct 11, 1991
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
Chemistry
22d
Cleared
Sep 27, 1991
BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO
Microbiology
93d
Cleared
Aug 29, 1991
BARTELS CLOSTRIDIUM DIFFICILE TOXIN A ENZYM IMMUN
Microbiology
38d
Cleared
Jul 22, 1991
ANTIGENZ CHLAMYDIA
Microbiology
49d
Cleared
Nov 22, 1988
INFLUENZA A IFA TEST FOR DIRECT ANTIGEN DETECTION
Microbiology
47d
Cleared
Nov 22, 1988
RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION
Microbiology
47d
Cleared
Nov 22, 1988
PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
Microbiology
47d
Cleared
Nov 22, 1988
PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT
Microbiology
47d