Medical Device Manufacturer · US , Mchenry , IL

Coulter Electronics, Inc.

101 submissions · 101 cleared · Since 1976
101
Total
101
Cleared
0
Denied

Coulter Electronics, Inc. — FDA 510(k) Submissions

Coulter Electronics, Inc. has submitted 101 FDA 510(k) premarket notifications since 1976, of which 101 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Cell, Automated (particle Counter), Counter, Differential Cell, Mixture, Hematology Quality Control, Nadh Oxidation/nad Reduction, Ast/sgot, Nadh Oxidation/nad Reduction, Alt/sgpt . Use the specialty filter in the sidebar to narrow results.

101 devices
1–25 of 101
CD8 CYTOSPHERES KIT
K923951 · MAM Dna-probe, B And T... · Hematology
Apr 1994 627d
COULTER RETIC-C CELL CONTROL
K930119 · JPK Mixture, Hematology... · Hematology
Apr 1993 83d
CD4 CYTOSPHERES KIT
K921279 · GKZ Counter, Differential Cell · Hematology
Dec 1992 287d
COULTER MULTI-Q-PREP
K923530 · GKH Apparatus, Automated... · Hematology
Oct 1992 90d
COULTER MH009
K922181 · GKZ Counter, Differential Cell · Hematology
Aug 1992 101d
COULTER MAXM W/ AUTOLOADER
K922704 · GKZ Counter, Differential Cell · Hematology
Jul 1992 52d
COULTER MH017
K921567 · GKZ Counter, Differential Cell · Hematology
Jul 1992 95d
PX COULTER(R) CELL CONTROL
K912133 · JPK Mixture, Hematology... · Hematology
Jul 1991 64d
COULTER(R) MH010
K911385 · GKZ Counter, Differential Cell · Hematology
Jun 1991 81d
COULTER DART AST (GOT) REAGENT
K905771 · CIT Nadh Oxidation/nad... · Chemistry
Feb 1991 61d
COULTER DART ALT (GPT) REAGENT
K905767 · CKA Nadh Oxidation/nad... · Chemistry
Jan 1991 29d
COULTER DIRECT BILLRUBIN REAGENT
K905622 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Dec 1990 12d
COULTER CK-MB ISOENZYME REAGENT
K904866 · JHT Chromatographic... · Chemistry
Dec 1990 45d
COULTER CHOLESTEROL REAGENT
K897162 · CHH Enzymatic... · Chemistry
Mar 1990 91d
COULTER TRIGLYCERIDES GPO REAGENT
K897159 · CDT Lipase... · Chemistry
Mar 1990 71d
COULTER GLUCOSE REAGENT
K897160 · CFR Hexokinase, Glucose · Chemistry
Mar 1990 71d
COULTER ALT (GPT) REAGENT
K897163 · CKA Nadh Oxidation/nad... · Chemistry
Mar 1990 71d
COULTER LD (LDH-L) REAGENT
K897164 · CFJ Nad Reduction/nadh... · Chemistry
Mar 1990 71d
COULTER URIC ACID REAGENT
K897161 · KNK Acid, Uric, Uricase... · Chemistry
Mar 1990 63d
COULTER AST (GOT) REAGENT
K897165 · CIT Nadh Oxidation/nad... · Chemistry
Feb 1990 57d
COULTER TOTAL PROTEIN REAGENT
K897166 · CEK Biuret (colorimetric),... · Chemistry
Feb 1990 57d
DART UREA NITROGEN
K894836 · CDQ Urease And Glutamic... · Chemistry
Oct 1989 91d
COULTER FLOW RETICULOCYTE REAGENT
K885332 · GKL Counter, Cell, Automated... · Hematology
Feb 1989 56d
COULTER 5P CONTROL
K885028 · GKZ Counter, Differential Cell · Hematology
Feb 1989 73d
COULTER STKS
K885093 · GKZ Counter, Differential Cell · Hematology
Dec 1988 19d

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