Maky 21.1 Dialyzer Reprocessing System
FDA 510(k) K024076 · Hdc Maquinolas, LLC
510(k) numberK024076
Submission
- Device name
- Maky 21.1 Dialyzer Reprocessing System
- Applicant
- Hdc Maquinolas, LLC
Pearland, TX, US - Received
- December 10, 2002
- Decision date
- September 26, 2003
- 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 |
| 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 |
| K970799 | Alexander Manufacturing Rechargeable Battery (M1/T)LIF · Traditional | Alexander Mfg. Co. | 05/14/1997SE |
Questions and answers
When was Maky 21.1 Dialyzer Reprocessing System cleared by the FDA?
Maky 21.1 Dialyzer Reprocessing System (K024076) received a 510(k) decision of Substantially Equivalent on September 26, 2003, 290 days after the submission was received.
What is the product code of K024076?
The FDA product code is LIF – Dialyzer Reprocessing System, a Class II (moderate risk) device regulated under 21 CFR 876.5820.