Medical Device Manufacturer · US , Mchenry , IL

Ulster Scientific, Inc.

20 submissions · 20 cleared · Since 1980
20
Total
20
Cleared
0
Denied

Ulster Scientific, Inc. — FDA 510(k) Submissions

Ulster Scientific, Inc. has submitted 20 FDA 510(k) premarket notifications since 1980, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, Test, Erythrocyte Sedimentation Rate, Syringe, Piston, Station, Pipetting And Diluting, For Clinical Use, Assay, Glycosylated Hemoglobin . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
FEATHER-TOUCH SINGLE-STICK DEVICE
K942620 · FMK Single Use Only Blood... · General & Plastic Surgery
Jun 1994 20d
UNISTIK
K920562 · FMK Single Use Only Blood... · General & Plastic Surgery
Mar 1992 50d
EPC ELECTRONIC PIPETTING SYSTEM
K902592 · JQW Station, Pipetting And... · Chemistry
Jul 1990 37d
AUTOPEN
K895890 · FMF Syringe, Piston · General Hospital
Feb 1990 134d
THE AUTOLET LITE
K894474 · FMK Single Use Only Blood... · General & Plastic Surgery
Aug 1989 31d
AIR DISPLACEMENT PIPETTE
K885340 · JQW Station, Pipetting And... · Chemistry
Feb 1989 48d
UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM
K875354 · LCP Assay, Glycosylated... · Hematology
Feb 1988 48d
NEUROTIPS(TM)
K871571 · GXB Esthesiometer · Neurology
Jun 1987 57d
WINPETTE
K871076 · JPH Test, Erythrocyte... · Hematology
Mar 1987 5d
ACCUPEN(R)
K870078 · FMF Syringe, Piston · General Hospital
Mar 1987 68d
USI AUTOJECT INSULIN SYRINGE
K864761 · FMF Syringe, Piston · General Hospital
Dec 1986 11d
NEONATAL UNILET
K861243 · FMK Single Use Only Blood... · General & Plastic Surgery
Apr 1986 27d
DISPETTE II
K860899 · JPH Test, Erythrocyte... · Hematology
Apr 1986 35d
DIAMATIC, AUTOMATIC INSULIN INJECTOR
K860284 · KZH Introducer, Syringe Needle · General Hospital
Apr 1986 69d
MICRO-MAT SYSTEM
K854962 · GKJ Spinner, Slide, Automated · Hematology
Dec 1985 12d
PRECI-JET 50
K851181 · KZE Injector, Fluid,... · General Hospital
Jun 1985 73d
UNILET LANCET
K842517 · FML Chair, Blood Donor · General Hospital
Sep 1984 72d
GLUCOKEY
K831194 · CGA Glucose Oxidase, Glucose · Hematology
Oct 1983 202d
WESTERGREN DISPETTE FOR ESR
K831195 · JPH Test, Erythrocyte... · Hematology
May 1983 27d
AUTOLET
K801815 · JCA Device, Bleeding Time · Hematology
Oct 1980 72d
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