Data / Medical devices / United States / IBT Scientific
IBT Scientific: FDA-registered device maker in Creedmoor, NC, United States, 3 510(k) clearances
IBT Scientific is registered with the FDA (registration 3029754060) in Creedmoor, NC, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 22, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029754060
- Address
- 1178 Telecom Drive, Creedmoor, NC, United States, 27522
- Owner or operator
- IBT Scientific LLC (10083938)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 31, 2021
- Registered through
- 2026
- Brand names listed
- Glutar Test 1; Forma Test, Peracid Test, QwikCheck Chemical Indicator, WaterCheck RC; WaterCheck CP; WaterCheck 2; RenalCheck PX, WaterSoft 0-30+ ppm Water Hardness Test, WaterSoft Water Hardness Test
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialyzer Reprocessing System | LIF | 2 | Manufacturer | accessdata.fda.gov |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 2 | Contract manufacturer | accessdata.fda.gov |
| Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis) | JRS | 1 | Manufacturer | accessdata.fda.gov |
| Strip, Test, Reagent, Residuals For Dialysate, Disinfectant | MSY | 2 | Manufacturer | accessdata.fda.gov |
| System, Dialysate Delivery, Single Patient | FKP | 2 | 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 |
|---|---|---|---|---|---|---|
| January 22, 2001 | K002011 | GLUTARTEST 1 REAGENT STRIP | MSY | Substantially Equivalent | Integrated Biomedical Technology, Inc. | accessdata.fda.gov |
| June 16, 1997 | K964264 | HIGH RANGE PEROXIDE TEST STRIP | FKP | Substantially Equivalent | Integrated Biomedical Technology, Inc. | accessdata.fda.gov |
| March 11, 1996 | K953854 | WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE | FKP | Substantially Equivalent | Integrated Biomedical Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Dialysate Delivery, Single Patient
- All makers of Dialyzer Reprocessing System
- All makers of Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
- All makers of Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)
- All makers of Indicator, Physical/Chemical Sterilization Process
Updated January 22, 2001. 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.