Medical Device Manufacturer · US , Mchenry , IL

Geometric Data, Div. Smithkline Corp.

18 submissions · 18 cleared · Since 1976
18
Total
18
Cleared
0
Denied

Geometric Data, Div. Smithkline Corp. — FDA 510(k) Submissions

Geometric Data, Div. Smithkline Corp. has submitted 18 FDA 510(k) premarket notifications since 1976, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Counter, Differential Cell, Spinner, Slide, Automated, Stains, Hematology, Device, Automated Cell-locating, Stain, Reticulocyte . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
AUTOLYZER 800
K841852 · GKZ Counter, Differential Cell · Hematology
Sep 1984 125d
HEMASPINNER
K811534 · GKJ Spinner, Slide, Automated · Hematology
Aug 1981 78d
HEMATRAK ABNORMAL RECOGNITION
K791041 · GKZ Counter, Differential Cell · Hematology
Sep 1979 91d
HEMATRAK MODEL 480
K790816 · GKZ Counter, Differential Cell · Hematology
Jul 1979 81d
CONTEXT FILTER
K791108 · GKZ Counter, Differential Cell · Hematology
Jul 1979 33d
STAIN, HEMASTAIN RETIC
K790042 · GJH Stain, Reticulocyte · Hematology
Feb 1979 41d
PLATELETS/CU MM
K780577 · GKZ Counter, Differential Cell · Hematology
May 1978 39d
RE-CELL SLIDE RECAP
K772139 · JOY Device, Automated... · Hematology
Jan 1978 52d
HEMATRAK RBC MORPHOLOGY
K761207 · GKZ Counter, Differential Cell · Hematology
Oct 1977 315d
HEMATRAK
K770680 · GKZ Counter, Differential Cell · Hematology
Jul 1977 81d
ATYPIA PROFILE MONITOR
K770550 · GKZ Counter, Differential Cell · Hematology
Jun 1977 88d
HEMATRAK MODEL 125
K770701 · GKZ Counter, Differential Cell · Hematology
Jun 1977 46d
ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION
K770869 · GKZ Counter, Differential Cell · Hematology
Jun 1977 20d
HEMATRAK MATURITY PROFILE OPTION
K761208 · GKZ Counter, Differential Cell · Hematology
Feb 1977 83d
BLOOD-SMEARING INSTRUMENT (MINIPREP TM)
K760007 · GKJ Spinner, Slide, Automated · Hematology
Sep 1976 87d
HEMASTAIN FIXATIVE
K760485 · KQC Stains, Hematology · Hematology
Aug 1976 10d
HEMASTAIN WRIGHT STAIN
K760486 · Cardiovascular
Aug 1976 10d
HEMASTAIN PHOSPHATE BUFFER
K760487 · KQC Stains, Hematology · Hematology
Aug 1976 10d
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