Formasure Test Reagent
FDA 510(k) K905217 · Di-Chem, Inc.
510(k) numberK905217
Submission
- Device name
- Formasure Test Reagent
- Applicant
- Di-Chem, Inc.
Maple Grove, MN, US - Received
- November 20, 1990
- Decision date
- April 9, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIF – Dialyzer Reprocessing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code LIF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091360 | Clearflux Dialyzer Reprocessing SystemLIF · Traditional | Novaflux Technologies | 11/03/2010SE |
| K043126 | Assist Header CleanerLIF · Traditional | Alcavis International, Inc. | 02/03/2005SE |
| K040660 | Sterichek Glutaraldehyde Reagent StripsLIF · Traditional | Hach Company | 11/15/2004SE |
| K033505 | Renaclean SH Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 04/27/2004SE |
| K024076 | Maky 21.1 Dialyzer Reprocessing SystemLIF · Traditional | Hdc Maquinolas, LLC | 09/26/2003SE |
| K013713 | Arm Automatic Reprocessing MachineLIF · Traditional | Alcavis International Incorporated | 07/15/2002SE |
| K992016 | Amukin DLIF · Traditional | Amuchina Intl., Inc. | 01/10/2000SE |
| K991851 | Renaclear Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 08/30/1999SE |
| K974426 | Potency Test Strips, Indicator Test StripsLIF · Traditional | Reprocessing Products Corp | 02/10/1999SE |
| K974798 | Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional | Environmental Test Systems, Inc. | 03/20/1998SE |
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| K202508 | Hemo-Lyte C CartridgeKPO · Traditional | 08/12/2022SE |
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| K012547 | Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate SolutionKPO · Traditional | 01/18/2002SE |
| K012328 | Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate PowderKPO · Traditional | 01/18/2002SE |
| K823103 | Dialysate Additives-Powder/LiquidKPO · Traditional | 11/17/1982SE |
Questions and answers
When was Formasure Test Reagent cleared by the FDA?
Formasure Test Reagent (K905217) received a 510(k) decision of Substantially Equivalent on April 9, 1991, 140 days after the submission was received.
What is the product code of K905217?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.