Medical Device Manufacturer · US , Miami , FL

Baxter Diagnostics, Inc.

72 submissions · 72 cleared · Since 1988
72
Total
72
Cleared
0
Denied

Baxter Diagnostics, Inc. — FDA 510(k) Submissions

Baxter Diagnostics, Inc. has submitted 72 FDA 510(k) premarket notifications since 1988, of which 72 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Manual Antimicrobial Susceptibility Test Systems, Multi-analyte Controls, All Kinds (assayed), Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific, Panels, Test, Susceptibility, Antimicrobial, Respiratory Syncytial Virus, Antigen, Antibody, Ifa . Use the specialty filter in the sidebar to narrow results.

72 devices
1–25 of 72
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K934458 · JWY Manual Antimicrobial... · Microbiology
Jul 1995 673d
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
K950817 · JWY Manual Antimicrobial... · Microbiology
Apr 1995 62d
DRIED GRAM-NEGATIVE MIC//COMBO PANELS
K935704 · LTT Panels, Test,... · Microbiology
Apr 1995 500d
STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
K950570 · JLS Radioimmunoassay,... · Chemistry
Apr 1995 67d
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K945235 · LTT Panels, Test,... · Microbiology
Mar 1995 131d
DRIED GRAM-NEGATIVE CEFPODOXIME
K941030 · LTT Panels, Test,... · Microbiology
Feb 1995 349d
LORACARBEF GRAM-NAGATIVE PANELS
K940917 · JWY Manual Antimicrobial... · Microbiology
Feb 1995 348d
GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX
K941459 · JWY Manual Antimicrobial... · Microbiology
Feb 1995 316d
DRIED GRAM NEGATIVE/CEFMETAZOLE
K941317 · JWY Manual Antimicrobial... · Microbiology
Jan 1995 319d
MICRODILUTION/LORACARBEF PANELS
K942089 · JWY Manual Antimicrobial... · Microbiology
Jan 1995 252d
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · JWY Manual Antimicrobial... · Microbiology
Jan 1995 244d
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K943510 · JWY Manual Antimicrobial... · Microbiology
Dec 1994 135d
STRATUS(R) THYROID UPTAKE FLUOR ENZYME IMMUNOASSAY
K933414 · KHQ Radioassay,... · Chemistry
Nov 1994 497d
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
K934003 · DKA Antiserum, Digoxin · Toxicology
Nov 1994 462d
DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA
K935307 · DDQ Antigen, Antiserum,... · Hematology
Nov 1994 385d
DADE INNOVIN II
K935702 · GJS Test, Time, Prothrombin · Hematology
Nov 1994 357d
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K944651 · JWY Manual Antimicrobial... · Microbiology
Nov 1994 53d
DRIED GRAM-POSITIVE MIC/COMBO PANELS, AMP/EXT DIL
K934323 · JWY Manual Antimicrobial... · Microbiology
Oct 1994 411d
FLEXTRANS
K935987 · JSM Culture Media,... · Microbiology
Aug 1994 244d
ANTITHROMBIN III CHROMOGENIC ASSAY
K936196 · JBQ Antithrombin Iii... · Hematology
May 1994 126d
PARAMAX ALCOHOL REAGENT
K934275 · DIC Alcohol Dehydrogenase,... · Toxicology
Apr 1994 238d
PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS
K935568 · DLZ Enzyme Immunoassay,... · Toxicology
Mar 1994 113d
PARAMAX(R) PHENYTOIN REAGENT
K932686 · DIP Enzyme Immunoassay,... · Toxicology
Nov 1993 176d
STRATUS FREE THYROXINE (FREE T4) FLUOROMETRIC
K932912 · CEC Radioimmunoassay, Free... · Chemistry
Oct 1993 134d
DADE ANEMIA/HEMOCHROMATOSIS CONTOLS,LEVEL 1,LEVEL 2,AND LEVEL 3
K933437 · JJY Multi-analyte Controls,... · Chemistry
Oct 1993 106d
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