Data / Medical devices / United States / Serim Research Corp.
Serim Research Corp.: FDA-registered device maker in Elkhart, IN, United States, 14 510(k) clearances
Serim Research Corp. is registered with the FDA (registration 1833387) in Elkhart, IN, United States. It lists 10 device types. The FDA files 14 510(k) clearances under its listings, the newest dated October 12, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1833387
- Address
- 3506 Reedy Dr, Elkhart, IN, United States, 46514
- Owner or operator
- Serim Research Corporation (9001543)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- December 14, 2007
- Registered through
- 2026
- Brand names listed
- Formaldehyde, Formaldehyde Test, OPAL, Serim DISINTEK GTA 1.5% Test Strips, Serim DISINTEK OPA Test Strips, Serim GUARDIAN Blood Leak, Serim GUARDIAN FINAL DIALYSATE pH, Serim GUARDIAN HiSENSE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector, Leak, Blood | FJD | 2 | Manufacturer | accessdata.fda.gov |
| Dialyzer Reprocessing System | LIF | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Blood, Dialysis | FKJ | 2 | Manufacturer | accessdata.fda.gov |
| Helicobacter Pylori | LYR | 1 | Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Sterilant, Medical Devices | MED | 2 | Manufacturer | accessdata.fda.gov |
| Strip, Dialysate Ph Indicator | MNV | 2 | Manufacturer | accessdata.fda.gov |
| Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | MSY | 2 | Manufacturer | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 2 | Manufacturer | accessdata.fda.gov |
| Test, Urine Leukocyte | LJX | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 12, 2012 | K120652 | RAPICIDE OPA-28 TEST STRIP | JOJ | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| September 25, 2008 | K082352 | SERIM DISINTEK OPA TEST STRIP | JOJ | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| July 11, 2008 | K081370 | SERIM DISINTEK OPA TEST STRIP | JOJ | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| May 6, 2008 | K080712 | SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 | MSY | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| November 30, 2001 | K012115 | SERIM BLOOD LEAK TEST STRIP-2 | FJD | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| May 5, 2000 | K000578 | SERIM LEUKOCYTE ESTERASE TEST STRIPS | LJX | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| December 18, 1995 | K953632 | SERIM PYLORITEK TEST KIT | LYR | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| August 9, 1995 | K952215 | SERIM HISENSE TEST KIT | FIP | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| February 1, 1995 | K945491 | SERIM(TM) BICARB PH REAGENT STRIPS | MNV | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| April 9, 1992 | K914123 | SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS | LIF | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| March 26, 1992 | K913943 | SERIM DISINTEK REAGENT STRIPS | MED | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| May 1, 1991 | K910320 | SERIM PERACETIC ACID REAGENT STRIPS | JOJ | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| September 13, 1990 | K901734 | SERIM RESIDUAL CHLORINE TEST KIT | FKJ | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
| July 11, 1990 | K900341 | SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT | LIF | Substantially Equivalent | Serim Research Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Urine Leukocyte
- All makers of Dialyzer Reprocessing System
- All makers of Indicator, Physical/Chemical Sterilization Process
- All makers of Subsystem, Water Purification
Updated October 12, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.