Serim Residual Formaldehyde Reagent Strips
FDA 510(k) K914123 · Serim Research Corp.
510(k) numberK914123
Submission
- Device name
- Serim Residual Formaldehyde Reagent Strips
- Applicant
- Serim Research Corp.
Elkhart, IN, US - Received
- September 13, 1991
- Decision date
- April 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Environmental Test Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253863 | GUARDIAN Quick Dip Residual Chlorine (5212)FKJ · Traditional | 03/17/2026SE |
| K251035 | DISINTEK PA Test StripsJOJ · Traditional | 06/03/2025SE |
| K202565 | WAVICIDE-OPA MEC IndicatorJOJ · Traditional | 12/02/2020SE |
| K192445 | QwikCheck Chemical IndicatorsJOJ · Traditional | 04/02/2020SE |
| K120652 | Rapicide OPA-28 Test StripJOJ · Traditional | 10/12/2012SE |
| K092346 | Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171JOJ · Traditional | 01/07/2010SE |
| K083295 | Serim Disintek Gta 2.1%, Model: 5164JOJ · Traditional | 03/16/2009SE |
| K082352 | Serim Disintek Opa Test StripJOJ · Traditional | 09/25/2008SE |
| K081370 | Serim Disintek Opa Test StripJOJ · Traditional | 07/11/2008SE |
| K080712 | Serim Hisense Ultra 0.1, Part Number 5167MSY · Traditional | 05/06/2008SE |
Questions and answers
When was Serim Residual Formaldehyde Reagent Strips cleared by the FDA?
Serim Residual Formaldehyde Reagent Strips (K914123) received a 510(k) decision of Substantially Equivalent on April 9, 1992, 209 days after the submission was received.
What is the product code of K914123?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.