Formalin Reuse Cart
FDA 510(k) K941757 · National Medical Care, Medical Products Div., Inc.
510(k) numberK941757
Submission
- Device name
- Formalin Reuse Cart
- Applicant
- National Medical Care, Medical Products Div., Inc.
Waltham, MA, US - Received
- April 8, 1994
- Decision date
- January 22, 1996
- 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 |
|---|---|---|
| K962081 | Combilines Hemodialysis Blood Tubing SetFJK · Traditional | 11/01/1996SE |
| K952343 | Focua 90R, 90HR, 120R, 120HR, 160R, 160HR Hollow Fiber DialyzerFJI · Traditional | 12/22/1995SE |
| K930843 | Rapid Disconnect Y-Set, Cat. No. 48-7000KDJ · Traditional | 08/31/1994SE |
| K914790 | Hollow Fiber Dialyzer Focus 9OR/90H-R/120R/120H-RFJI · Traditional | 03/05/1993SE |
| K920797 | Hemodialysis Blood Tubing SetFJK · Traditional | 09/21/1992SE |
| K920697 | Dextrolyte II Peritoneal Dialysis 48-3029-7 ClampFJH · Traditional | 09/21/1992SE |
| K920693 | Dextrolyte II Peritoneal Dialysis 48-3028-9FJG · Traditional | 09/21/1992SE |
| K920586 | Dextrolyte II Peritoneal Dialysis Admin. SetKDJ · Traditional | 09/21/1992SE |
| K920029 | Dextrolyte II Capd Trnsfer SetKDJ · Traditional | 09/21/1992SE |
| K915628 | Dextrolyte II Peritoneal Dialysis PumpKDJ · Traditional | 03/16/1992SE |
Questions and answers
When was Formalin Reuse Cart cleared by the FDA?
Formalin Reuse Cart (K941757) received a 510(k) decision of Substantially Equivalent on January 22, 1996, 654 days after the submission was received.
What is the product code of K941757?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.