Medical Device Manufacturer · US , Elkhart , IN

Serim Research Corp.

27 submissions · 27 cleared · Since 1990
27
Total
27
Cleared
0
Denied

Serim Research Corp. — FDA 510(k) Submissions

Serim Research Corp. has submitted 27 FDA 510(k) premarket notifications since 1990, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Indicator, Physical/chemical Sterilization Process, Dialyzer Reprocessing System, Detector, Leak, Blood, Helicobacter Pylori, Sterilant, Medical Devices . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
RAPICIDE OPA-28 TEST STRIP
K120652 · JOJ Indicator,... · General Hospital
Oct 2012 224d
SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
K092346 · JOJ Indicator,... · General Hospital
Jan 2010 156d
SERIM DISINTEK GTA 2.1%, MODEL: 5164
K083295 · JOJ Indicator,... · General Hospital
Mar 2009 126d
SERIM DISINTEK OPA TEST STRIP
K082352 · JOJ Indicator,... · General Hospital
Sep 2008 40d
SERIM DISINTEK OPA TEST STRIP
K081370 · JOJ Indicator,... · General Hospital
Jul 2008 57d
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
K080712 · MSY Strip, Test, Reagent,... · Gastroenterology & Urology
May 2008 54d
SERIM PERACETIC ACID CHEMICAL INDICATOR
K052388 · JOJ Indicator,... · General Hospital
Dec 2005 92d
SERIM DIALYSATE MONITOR TEST STRIP
K043031 · NTZ Strip, Dialysate, Ph,... · Gastroenterology & Urology
Jun 2005 222d
PYLORITEK VP TEST KIT 5140VP
K014038 · LYR Helicobacter Pylori · Microbiology
Feb 2002 63d
SERIM BLOOD LEAK TEST STRIP-2
K012115 · FJD Detector, Leak, Blood · Gastroenterology & Urology
Nov 2001 147d
SERIM LEUKOCYTE ESTERASE TEST STRIPS
K000578 · LJX Test, Urine Leukocyte · Hematology
May 2000 73d
CIDEX OPA SOLUTION TEST STRIP
K992341 · JOJ Indicator,... · General Hospital
Nov 1999 133d
SERIM BLOOD LEAK TEST STRIP
K990206 · FJD Detector, Leak, Blood · Gastroenterology & Urology
Apr 1999 90d
SPOROX TEST STRIPS
K972035 · JOJ Indicator,... · General Hospital
Aug 1997 88d
SERIM PYLORITEK TEST KIT
K953632 · LYR Helicobacter Pylori · Microbiology
Dec 1995 151d
SERIM HISENSE TEST KIT
K952215 · FIP Subsystem, Water... · Gastroenterology & Urology
Aug 1995 90d
SERIM(TM) BICARB PH REAGENT STRIPS
K945491 · MNV Strip, Dialysate Ph... · Gastroenterology & Urology
Feb 1995 85d
WAVICIDE MONITOR STRIPS
K932047 · MED Sterilant, Medical Devices · General Hospital
Jun 1994 401d
SERIM PYLORITEK REAGENT STRIPS
K936034 · JTO Discs, Strips And... · Microbiology
Apr 1994 127d
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
K914123 · LIF Dialyzer Reprocessing System · Gastroenterology & Urology
Apr 1992 209d
SERIM DISINTEK REAGENT STRIPS
K913943 · MED Sterilant, Medical Devices · General Hospital
Mar 1992 204d
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
K911628 · LIF Dialyzer Reprocessing System · Gastroenterology & Urology
Jun 1991 77d
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
K911629 · LIF Dialyzer Reprocessing System · Gastroenterology & Urology
Jun 1991 77d
SERIM PERACETIC ACID REAGENT STRIPS
K910320 · JOJ Indicator,... · General Hospital
May 1991 97d
SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT
K902227 · LIF Dialyzer Reprocessing System · Gastroenterology & Urology
Apr 1991 320d
Filters