IBT Scientific

FDA Device Registration & Listing · Creedmoor, NC, US · Registration 3029754060

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029754060
FEI Number
3029754060
Entity Name
IBT Scientific
City/State/Country
Creedmoor, NC, US
Establishment Address
1178 Telecom Drive, Creedmoor, NC 27522, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
IBT Scientific LLC (Owner Number: 10083938)
Owner / Operator Contact Address
2931 Moose Trail, Elkhart, IN 46514, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

WaterSoft Water Hardness Test WaterSoft 0-30+ ppm Water Hardness Test WaterCheck RC; WaterCheck CP; WaterCheck 2; RenalCheck PX QwikCheck™ Chemical Indicator

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JRS Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) Clinical Chemistry Class 1 862.2050 2024-09-29
FKP System, Dialysate Delivery, Single Patient Gastroenterology, Urology Class 2 876.5820 2021-12-31
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-02-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IBT Scientific LLC
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
K894838 Baxter Healthcare Corp HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB 1989-09-07

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029754060. Last updated year: 2026. Please use registration number 3029754060 when referencing this establishment in official correspondence.
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