Serim Research Corp.
Elkhart, IN, US
SERIM RESEARCH CORP. appears in FDA device records in Elkhart, IN. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 31 510(k) clearances for Serim Research Corp. between 1990 and 2026. The busiest year on record is 1991, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 2 |
| 1991 | 4 |
| 1992 | 2 |
| 1994 | 2 |
| 1995 | 3 |
| 1997 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2005 | 2 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2020 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253863 | GUARDIAN™ Quick Dip Residual Chlorine (5212) | FKJ | Substantially Equivalent | |
| K251035 | DISINTEK™ PA Test Strips | JOJ | Substantially Equivalent | |
| K202565 | WAVICIDE-OPA MEC Indicator | JOJ | Substantially Equivalent | |
| K192445 | QwikCheck Chemical Indicators | JOJ | Substantially Equivalent | |
| K120652 | RAPICIDE OPA-28 TEST STRIP | JOJ | Substantially Equivalent | |
| K092346 | SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 | JOJ | Substantially Equivalent | |
| K083295 | SERIM DISINTEK GTA 2.1%, MODEL: 5164 | JOJ | Substantially Equivalent | |
| K082352 | SERIM DISINTEK OPA TEST STRIP | JOJ | Substantially Equivalent | |
| K081370 | SERIM DISINTEK OPA TEST STRIP | JOJ | Substantially Equivalent | |
| K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 | MSY | Substantially Equivalent | |
| K052388 | SERIM PERACETIC ACID CHEMICAL INDICATOR | JOJ | Substantially Equivalent | |
| K043031 | SERIM DIALYSATE MONITOR TEST STRIP | NTZ | Substantially Equivalent | |
| K014038 | PYLORITEK VP TEST KIT 5140VP | LYR | Substantially Equivalent | |
| K012115 | SERIM BLOOD LEAK TEST STRIP-2 | FJD | Substantially Equivalent | |
| K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | LJX | Substantially Equivalent | |
| K992341 | CIDEX OPA SOLUTION TEST STRIP | JOJ | Substantially Equivalent | |
| K990206 | SERIM BLOOD LEAK TEST STRIP | FJD | Substantially Equivalent | |
| K972035 | SPOROX TEST STRIPS | JOJ | Substantially Equivalent | |
| K953632 | SERIM PYLORITEK TEST KIT | LYR | Substantially Equivalent | |
| K952215 | SERIM HISENSE TEST KIT | FIP | Substantially Equivalent | |
| K945491 | SERIM(TM) BICARB PH REAGENT STRIPS | MNV | Substantially Equivalent | |
| K932047 | WAVICIDE MONITOR STRIPS | MED | Substantially Equivalent | |
| K936034 | SERIM PYLORITEK REAGENT STRIPS | JTO | Substantially Equivalent | |
| K914123 | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS | LIF | Substantially Equivalent | |
| K913943 | SERIM DISINTEK REAGENT STRIPS | MED | Substantially Equivalent | |
| K911629 | SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) | LIF | Substantially Equivalent | |
| K911628 | SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) | LIF | Substantially Equivalent | |
| K910320 | SERIM PERACETIC ACID REAGENT STRIPS | JOJ | Substantially Equivalent | |
| K902227 | SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT | LIF | Substantially Equivalent | |
| K901734 | SERIM RESIDUAL CHLORINE TEST KIT | FKJ | Substantially Equivalent | |
| K900341 | SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT | LIF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1833387 | 1833387 | SERIM RESEARCH CORP. | 3506 Reedy Dr, ELKHART, IN 46514 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FJDDetector, Leak, Blood
- LIFDialyzer Reprocessing System
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- FKJFilter, Blood, Dialysis
- LYRHelicobacter Pylori
- JOJIndicator, Physical/Chemical Sterilization Process
- MEDSterilant, Medical Devices
- MNVStrip, Dialysate Ph Indicator
- NTZStrip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator
- MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant
- FIPSubsystem, Water Purification
- LJXTest, Urine Leukocyte
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain