510(k) K874034
- Device
- ADR-22 AUTOMATIC DIALYZER REPROCESSOR
- Applicant
- BIODYNAMICS CORP.
- 510(k) number
- K874034
- Product code
- LIF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-23
- Date received
- 1987-10-05
- Regulation
- 876.5820
- Classification name
- Dialyzer Reprocessing System
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD L BENSON
- Address
- 6611 Portwest Dr. Suite 190 Houston TX US 77024 77024
FDA Registration Numbers#
- 2028411
- 3029754060
- 1932668
- 2013736
- 1833387
- 3019131
- 3002735238
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LIF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091360 | CLEARFLUX DIALYZER REPROCESSING SYSTEM | Novaflux Technologies | 2010-11-03 |
| K043126 | ASSIST HEADER CLEANER | Alcavis International, Inc. | 2005-02-03 |
| K040660 | STERICHEK GLUTARALDEHYDE REAGENT STRIPS | Hach Company | 2004-11-15 |
| K033505 | RENACLEAN SH DIALYZER CLEANING SYSTEM | Minntech Corp. | 2004-04-27 |
| K024076 | MAKY 21.1 DIALYZER REPROCESSING SYSTEM | Hdc Maquinolas, LLC | 2003-09-26 |
| K013713 | ARM AUTOMATIC REPROCESSING MACHINE | Alcavis International Incorporated | 2002-07-15 |
| K992016 | AMUKIN D | Amuchina Intl., Inc. | 2000-01-10 |
| K991851 | RENACLEAR DIALYZER CLEANING SYSTEM | Minntech Corp. | 1999-08-30 |
| K974426 | POTENCY TEST STRIPS, INDICATOR TEST STRIPS | Reprocessing Products Corp | 1999-02-10 |
| K974798 | STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS | Environmental Test Systems, Inc. | 1998-03-20 |
| K970799 | ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) | Alexander Mfg. Co. | 1997-05-14 |
| K955299 | DPS 4 DIALYZER PREPARATION SYSTEM | Seratronics, Inc. | 1996-10-21 |
| K931336 | DRS 4 DIALYZER REPROCESSING SYSTEM | Seratronics, Inc. | 1996-04-18 |
| K941867 | RENALIN REUSE CART | Renal Scientific Service, Inc. | 1996-01-22 |
| K941757 | FORMALIN REUSE CART | National Medical Care, Medical Products Div., Inc. | 1996-01-22 |
Legacy Summary#
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FDA Review#
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