Serim Research Corp.
Medical device manufacturer in Elkhart, IN.
31510(k) clearances
0PMA approvals
0recalls
Device types
- JOJ Indicator, Physical/Chemical Sterilization… 12
- LIF Dialyzer Reprocessing System 5
- FKJ Filter, Blood, Dialysis 2
- MED Sterilant, Medical Devices 2
- LYR Helicobacter Pylori 2
- FJD Detector, Leak, Blood 2
- JTO Discs, Strips And Reagents, Microorganism… 1
- MNV Strip, Dialysate Ph Indicator 1
- FIP Subsystem, Water Purification 1
- LJX Test, Urine Leukocyte 1
- NTZ Strip, Dialysate, Ph, Bicarbonate, Glucose… 1
- MSY Strip, Test, Reagent, Residuals For… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253863 | GUARDIAN Quick Dip Residual Chlorine (5212)FKJ · Traditional | 03/17/2026SE |
| K251035 | DISINTEK PA Test StripsJOJ · Traditional | 06/03/2025SE |
| K202565 | WAVICIDE-OPA MEC IndicatorJOJ · Traditional | 12/02/2020SE |
| K192445 | QwikCheck Chemical IndicatorsJOJ · Traditional | 04/02/2020SE |
| K120652 | Rapicide OPA-28 Test StripJOJ · Traditional | 10/12/2012SE |
| K092346 | Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171JOJ · Traditional | 01/07/2010SE |
| K083295 | Serim Disintek Gta 2.1%, Model: 5164JOJ · Traditional | 03/16/2009SE |
| K082352 | Serim Disintek Opa Test StripJOJ · Traditional | 09/25/2008SE |
| K081370 | Serim Disintek Opa Test StripJOJ · Traditional | 07/11/2008SE |
| K080712 | Serim Hisense Ultra 0.1, Part Number 5167MSY · Traditional | 05/06/2008SE |
| K052388 | Serim Peracetic Acid Chemical IndicatorJOJ · Traditional | 12/01/2005SE |
| K043031 | Serim Dialysate Monitor Test StripNTZ · Traditional | 06/13/2005SE |
| K014038 | Pyloritek VP Test Kit 5140VPLYR · Traditional | 02/08/2002SE |
| K012115 | Serim Blood Leak Test STRIP-2FJD · Traditional | 11/30/2001SE |
| K000578 | Serim Leukocyte Esterase Test StripsLJX · Traditional | 05/05/2000SE |
| K992341 | Cidex Opa Solution Test StripJOJ · Traditional | 11/23/1999SE |
| K990206 | Serim Blood Leak Test StripFJD · Traditional | 04/21/1999SE |
| K972035 | Sporox Test StripsJOJ · Traditional | 08/29/1997SE |
| K953632 | Serim Pyloritek Test KitLYR · Traditional | 12/18/1995SE |
| K952215 | Serim Hisense Test KitFIP · Traditional | 08/09/1995SE |
| K945491 | Serim(Tm) Bicarb PH Reagent StripsMNV · Traditional | 02/01/1995SE |
| K932047 | Wavicide Monitor StripsMED · Traditional | 06/02/1994SE |
| K936034 | Serim Pyloritek Reagent StripsJTO · Traditional | 04/21/1994SE |
| K914123 | Serim Residual Formaldehyde Reagent StripsLIF · Traditional | 04/09/1992SE |
| K913943 | Serim Disintek Reagent StripsMED · Traditional | 03/26/1992SE |
| K911629 | Serim Formaldehyde Reagent Strips (2.5% -4.0%)LIF · Traditional | 06/27/1991SE |
| K911628 | Serim Formaldehyde Reagent Strips (1.O% -2.0%)LIF · Traditional | 06/27/1991SE |
| K910320 | Serim Peracetic Acid Reagent StripsJOJ · Traditional | 05/01/1991SE |
| K902227 | Serim Glutaraldehyde/Nephrex Potency Test KitLIF · Traditional | 04/02/1991SE |
| K901734 | Serim Residual Chlorine Test KitFKJ · Traditional | 09/13/1990SE |
| K900341 | Serim Residual Peroxide/Renalin Test KitLIF · Traditional | 07/11/1990SE |