Medical Device Manufacturer · US , Portland , OR

Crestat Diagnostics, Inc.

29 submissions · 29 cleared · Since 1990
29
Total
29
Cleared
0
Denied

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

Crestat Diagnostics, Inc. has submitted 29 FDA 510(k) premarket notifications since 1990, of which 29 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Method, Nephelometric, Immunoglobulins (g, A, M), Alpha-1-lipoprotein, Antigen, Antiserum, Control, Complement C4, Antigen, Antiserum, Control, Diazo Colorimetry, Bilirubin, C-reactive Protein, Antigen, Antiserum, And Control . Use the specialty filter in the sidebar to narrow results.

29 devices
1–25 of 29
N-ASSAY GLU-UL
K980883 · CFR Hexokinase, Glucose · Chemistry
Sep 1998 178d
N-ASSAY L D-BIL
K981276 · CIG Diazo Colorimetry, Bilirubin · Chemistry
May 1998 23d
N-ASSAY L T-BIL
K981289 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Apr 1998 19d
N-ASSAY CPK-L
K980900 · CGS Nad Reduction/nadh... · Chemistry
Mar 1998 16d
N-ASSAY L AST/GOT
K980902 · CIT Nadh Oxidation/nad... · Chemistry
Mar 1998 16d
N-ASSAY TIA PLASMINOGEN TEST KIT
K971985 · GGP Test, Qualitative And... · Hematology
Oct 1997 144d
N-ASSAY TIA ANTITHROMBIN III TEST KIT
K972257 · DDQ Antigen, Antiserum,... · Hematology
Oct 1997 125d
N-ASSAY TIA APO A1 TEST KIT
K964292 · DER Alpha-1-lipoprotein,... · Immunology
Aug 1997 276d
N-ASSAY TIA APO A1/B MULTI CALIBRATOR
K964294 · DER Alpha-1-lipoprotein,... · Immunology
Aug 1997 276d
N-ASSAY TIA APO B TEST KIT
K964296 · DER Alpha-1-lipoprotein,... · Immunology
Aug 1997 276d
N-ASSAY TIA C4 TEST KIT
K964297 · DBI Complement C4, Antigen,... · Immunology
Jul 1997 258d
N-ASSAY TIA MULTI V-NL
K964298 · CZW Complement C3, Antigen,... · Immunology
Jul 1997 258d
N-ASSAY TIA MULTI V-NL
K964299 · LKL Alpha-1-acid-glycoprotein... · Immunology
Jul 1997 258d
N-ASSAY TIA MULTI V-NL
K964300 · DBI Complement C4, Antigen,... · Immunology
Jul 1997 258d
N-ASSAY TIA MULTI V-NL
K964301 · DAD Haptoglobin, Antigen,... · Immunology
Jul 1997 258d
N-ASSAY TIA C1-INACTIVATOR TEST KIT
K965024 · DBA Complement C1 Inhibitor... · Immunology
Jul 1997 209d
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
K965100 · DEM Alpha-1-antitrypsin,... · Immunology
Jul 1997 206d
N-ASSAY TIA MULTI CRP CALIBRATOR SET
K965110 · DCK C-reactive Protein,... · Immunology
Jul 1997 195d
N-ASSAY TIA TRANSFERRIN TEST KIT
K964295 · DDG Transferrin, Antigen,... · Immunology
Jun 1997 230d
N-ASSAY TIA FIBRINOGEN TEST KIT
K965113 · KQJ System, Fibrinogen... · Hematology
Apr 1997 117d
N-ASSAY TIA IGM
K933970 · CFN Method, Nephelometric,... · Immunology
Mar 1994 221d
N-ASSAY TIA IGA
K933971 · CFN Method, Nephelometric,... · Immunology
Mar 1994 221d
N-ASSAY TIA IGG
K933972 · CFF Immunoelectrophoretic,... · Immunology
Mar 1994 221d
N-ASSAY TIA MULTI V-NL
K933973 · CFN Method, Nephelometric,... · Immunology
Jan 1994 168d
N-ASSAY TIA MICROALBUMIN
K934146 · JIR Indicator Method, Protein... · Chemistry
Jan 1994 140d
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