Medical Device Manufacturer · US , Mchenry , IL

Neometrics, Inc.

21 submissions · 21 cleared · Since 1978
21
Total
21
Cleared
0
Denied

Neometrics, Inc. — FDA 510(k) Submissions

Neometrics, Inc. has submitted 21 FDA 510(k) premarket notifications since 1978, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wire, Guide, Catheter, Endoscopic Guidewire, Gastroenterology-urology, Radioimmunoassay, Thyroid-stimulating Hormone, Radioimmunoassay, Total Thyroxine, Device, Percutaneous Retrieval . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
Bard Snare Retrieval Kit
K152560 · MMX Device, Percutaneous... · Cardiovascular
Oct 2015 44d
NovaGold High Performance Guidewire
K150225 · OCY Endoscopic Guidewire,... · Gastroenterology & Urology
Mar 2015 42d
Spring Coil Guidewire
K143135 · DQX Wire, Guide, Catheter · Cardiovascular
Feb 2015 112d
NOVAGOLD HIGH PERFORMANCE GUIDEWIRE
K133076 · OCY Endoscopic Guidewire,... · Gastroenterology & Urology
Feb 2014 143d
NEO ERCP GUIDEWIRE
K123439 · OCY Endoscopic Guidewire,... · Gastroenterology & Urology
Jan 2013 56d
NEOWIRE PTA/PTCA GUIDEWIRE
K101729 · DQX Wire, Guide, Catheter · Cardiovascular
Sep 2010 94d
VASCUPUNCTURE PICC GUIDEWIRE
K070150 · DQX Wire, Guide, Catheter · Cardiovascular
Feb 2007 30d
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
K043398 · DQX Wire, Guide, Catheter · Cardiovascular
Mar 2005 81d
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
K040786 · DQX Wire, Guide, Catheter · Cardiovascular
Apr 2004 21d
SELECTIVA SB GUIDEWIRE
K033321 · DQX Wire, Guide, Catheter · Cardiovascular
Nov 2003 21d
VASCUPUNCTURE PICC GUIDEWIRE
K031652 · DQX Wire, Guide, Catheter · Cardiovascular
Sep 2003 125d
VASCUPUNCTURE ACCESS WIRE
K012861 · DQX Wire, Guide, Catheter · Cardiovascular
Feb 2002 165d
SELECTIVA GUIDEWIRE
K013024 · DQX Wire, Guide, Catheter · Cardiovascular
Dec 2001 88d
ACCUWELL TSH, MODEL KAW-TSH-960
K001455 · JLW Radioimmunoassay,... · Chemistry
Nov 2000 177d
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
K991498 · JIA Enzymatic Methods, Galactose · Chemistry
Jun 1999 48d
ACCUWELL PHENYLALANINE ASSAY
K974047 · JNB Ninhydrin And... · Chemistry
Dec 1997 42d
ACCUWELL T4-EIA
K972974 · KLI Enzyme Immunoassay,... · Chemistry
Oct 1997 56d
ACCUSCREEN 17-HYDROXYPROGESTERONE
K934178 · JLX Radioimmunoassay,... · Chemistry
Mar 1995 580d
NEOCOAT T4
K901939 · CDX Radioimmunoassay, Total... · Chemistry
May 1990 31d
ACCUSCREEN TSH
K843281 · JLW Radioimmunoassay,... · Chemistry
Sep 1984 37d
ACCUSCREEN T4
K781222 · CDX Radioimmunoassay, Total... · Chemistry
Nov 1978 114d
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