Company · US
Serim Research Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2026. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | 12 |
| LIF | Dialyzer Reprocessing System | 5 |
| FJD | Detector, Leak, Blood | 2 |
| FKJ | Filter, Blood, Dialysis | 2 |
| LYR | Helicobacter Pylori | 2 |
| MED | Sterilant, Medical Devices | 2 |
| FIP | Subsystem, Water Purification | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 |
| LJX | Test, Urine Leukocyte | 1 |
| MNV | Strip, Dialysate Ph Indicator | 1 |
| MSY | Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | 1 |
| NTZ | Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 2026 | K253863 | GUARDIAN Quick Dip Residual Chlorine (5212) Serim Research | FKJ |
| Jun 3, 2025 | K251035 | DISINTEK PA Test Strips Serim Research | JOJ |
| Dec 2, 2020 | K202565 | WAVICIDE-OPA MEC Indicator Serim Research Corporation | JOJ |
| Apr 2, 2020 | K192445 | QwikCheck Chemical Indicators Serim Research Corporation | JOJ |
| Oct 12, 2012 | K120652 | RAPICIDE OPA-28 TEST STRIP Serim Research Corp. | JOJ |
| Jan 7, 2010 | K092346 | SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 Serim Research Corp. | JOJ |
| Mar 16, 2009 | K083295 | SERIM DISINTEK GTA 2.1%, MODEL: 5164 Serim Research Corp. | JOJ |
| Sep 25, 2008 | K082352 | SERIM DISINTEK OPA TEST STRIP Serim Research Corp. | JOJ |
| Jul 11, 2008 | K081370 | SERIM DISINTEK OPA TEST STRIP Serim Research Corp. | JOJ |
| May 6, 2008 | K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 Serim Research Corp. | MSY |
| Dec 1, 2005 | K052388 | SERIM PERACETIC ACID CHEMICAL INDICATOR Serim Research Corp. | JOJ |
| Jun 13, 2005 | K043031 | SERIM DIALYSATE MONITOR TEST STRIP Serim Research Corp. | NTZ |
| Feb 8, 2002 | K014038 | PYLORITEK VP TEST KIT 5140VP Serim Research Corp. | LYR |
| Nov 30, 2001 | K012115 | SERIM BLOOD LEAK TEST STRIP-2 Serim Research Corp. | FJD |
| May 5, 2000 | K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS Serim Research Corp. | LJX |
| Nov 23, 1999 | K992341 | CIDEX OPA SOLUTION TEST STRIP Serim Research Corp. | JOJ |
| Apr 21, 1999 | K990206 | SERIM BLOOD LEAK TEST STRIP Serim Research Corp. | FJD |
| Aug 29, 1997 | K972035 | SPOROX TEST STRIPS Serim Research Corp. | JOJ |
| Dec 18, 1995 | K953632 | SERIM PYLORITEK TEST KIT Serim Research Corp. | LYR |
| Aug 9, 1995 | K952215 | SERIM HISENSE TEST KIT Serim Research Corp. | FIP |
| Feb 1, 1995 | K945491 | SERIM(TM) BICARB PH REAGENT STRIPS Serim Research Corp. | MNV |
| Jun 2, 1994 | K932047 | WAVICIDE MONITOR STRIPS Serim Research Corp. | MED |
| Apr 21, 1994 | K936034 | SERIM PYLORITEK REAGENT STRIPS Serim Research Corp. | JTO |
| Apr 9, 1992 | K914123 | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS Serim Research Corp. | LIF |
| Mar 26, 1992 | K913943 | SERIM DISINTEK REAGENT STRIPS Serim Research Corp. | MED |
| Jun 27, 1991 | K911629 | SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%) Serim Research Corp. | LIF |
| Jun 27, 1991 | K911628 | SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%) Serim Research Corp. | LIF |
| May 1, 1991 | K910320 | SERIM PERACETIC ACID REAGENT STRIPS Serim Research Corp. | JOJ |
| Apr 2, 1991 | K902227 | SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT Serim Research Corp. | LIF |
| Sep 13, 1990 | K901734 | SERIM RESIDUAL CHLORINE TEST KIT Serim Research Corp. | FKJ |
| Jul 11, 1990 | K900341 | SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT Serim Research Corp. | LIF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||