Potency Test Strips, Indicator Test Strips
FDA 510(k) K974426 · Reprocessing Products Corp
510(k) numberK974426
Submission
- Device name
- Potency Test Strips, Indicator Test Strips
- Applicant
- Reprocessing Products Corp
Maple Grove, MN, US - Received
- October 27, 1997
- Decision date
- February 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K974798 | Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional | Environmental Test Systems, Inc. | 03/20/1998SE |
| K970799 | Alexander Manufacturing Rechargeable Battery (M1/T)LIF · Traditional | Alexander Mfg. Co. | 05/14/1997SE |
More from Alexander Mfg. Co.
| 510(k) | Device | Decision |
|---|---|---|
| K123805 | E-Z Chek Blood Leak Test StripsFJD · Traditional | 03/20/2013SE |
| K101750 | RPC E-Z Chek 6.8-8.5 PH Test Strips, Model K100-0117 and E-Z Chek 0-14 PH Test Strips…MNV · Traditional | 01/07/2011SE |
| K090338 | Ultra Low Total Chlorine, E-Z Chek Sensitive Total ChlorineMSY · Traditional | 05/08/2009SE |
| K974064 | Micro X Residual Test StripsMSY · Traditional | 12/07/1998SE |
| K950602 | Port Caps (Protective Closures Foe Reprocessed HemodialyzersFJI · Traditional | 11/30/1995SE |
Questions and answers
When was Potency Test Strips, Indicator Test Strips cleared by the FDA?
Potency Test Strips, Indicator Test Strips (K974426) received a 510(k) decision of Substantially Equivalent on February 10, 1999, 471 days after the submission was received.
What is the product code of K974426?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.