Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1833387

FEI Number

1833387

Entity Name

SERIM RESEARCH CORP.

City/State/Country

ELKHART, IN, US

Establishment Address

3506 Reedy Dr, ELKHART, IN 46514, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SERIM RESEARCH CORP. (Owner Number: 9001543)

Owner / Operator Contact Address

3506 REEDY DR., --, Elkhart, IN 46514, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081370

PMA Number

N/A

All Registered Proprietary Names

Formaldehyde Formaldehyde Test Serim GUARDIAN HiSENSE OPAL Serim GUARDIAN Blood Leak Serim DISINTEK GTA 1.5% Test Strips Serim DISINTEK OPA Test Strips Serim GUARDIAN Residual Peroxide Serim PeriScreen Test Strips Serim PyloriTek Reagent Strips Serim GUARDIAN BICARB pH II Serim GUARDIAN HiSENSE Ultra 0.1 Test Strips Serim DISINTEK OPA Test Strips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIF	Dialyzer Reprocessing System	Gastroenterology, Urology	Class 2	876.5820	2007-12-14
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2007-12-14
FIP	Subsystem, Water Purification	Gastroenterology, Urology	Class 2	876.5665	2007-12-14
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2013-01-15
FJD	Detector, Leak, Blood	Gastroenterology, Urology	Class 2	876.5820	2007-12-14
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2007-12-14
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2008-10-09
LIF	Dialyzer Reprocessing System	Gastroenterology, Urology	Class 2	876.5820	2007-12-14
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2007-12-14
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2007-12-14
MNV	Strip, Dialysate Ph Indicator	Gastroenterology, Urology	Class 2	876.5820	2007-12-14
MSY	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant	Gastroenterology, Urology	Class 2	876.5665	2008-10-09
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2008-10-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SERIM RESEARCH CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K110578	Mar Cor Purification, Inc.	MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM	2011-05-20
K033381	Discus Dental, Inc.	DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL	2004-01-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0004-05	Ameriwater Inc	2	AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.

Similar Registrations

Registration Number	Establishment Name	Location
3019131	Evoqua Water Technologies LLC	Minneapolis, MN, US
2028411	REPROCESSING PRODUCTS CORPORATION (RPC)	TUCSON, AZ, US
2013736	MEDICAL CHEMICAL CORPORATION	TORRANCE, CA, US
3002735238	NOVAFLUX, INC.	Princeton, NJ, US
3007412809	STERIS Corporation	FRANKLIN PARK, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1833387. Last updated year: 2026. Please use registration number 1833387 when referencing this establishment in official correspondence.