510(k) K860297
- Device
- Hemodialysis Concentrate Formulations/additives
- Applicant
- RENAL HYGIENICS
- 510(k) number
- K860297
- Product code
- FKQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-04
- Date received
- 1986-01-28
- Regulation
- 876.5820
- Classification name
- System, Dialysate Delivery, Central Multiple Patient
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERIC KLUMPH
- Address
- 18425 Burbank Blvd., Suite 411 Tarzana CA US 91356 91356
FDA Registration Numbers#
- 3004201412
- 1061927
- 3013764800
- 3004176176
- 9610825
- 3008102042
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FKQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052764 | DIACAP ULTRA DIALYSIS FLUID FILTER | B. Braun Medizintechnologie GmbH | 2006-06-09 |
| K893612 | TWO TANK DISSOLUTION MODULE | National Medical Care, Medical Products Div., Inc. | 1989-07-24 |
| K874084 | MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM | National Medical Care, Medical Products Div., Inc. | 1988-04-27 |
| K873421 | KAWASUMI A.V. FISTULA SET | Kawasumi Laboratories Co., Ltd. | 1987-10-09 |
| K870889 | ACID FUCHSIN SOLUTIONS | D.R.G. Scientific Industries | 1987-07-08 |
| K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT | Renal Systems, Inc. | 1987-06-09 |
| K864635 | FOUR TANK DISSOLUTION MODULE | National Medical Care, Medical Products Div., Inc. | 1987-01-13 |
| K862304 | DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM | Cd Medical, Inc. | 1986-09-09 |
| K861472 | MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 | National Medical Care, Medical Products Div., Inc. | 1986-07-10 |
| K852359 | AMUCHINA/DIALYZER DISINFECTANT | Amuchina Intl., Inc. | 1986-05-13 |
| K860296 | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES | Physicians Surgeons Purchasing Group | 1986-03-04 |
| K860336 | HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS | Breem Laboratories | 1986-03-04 |
| K854391 | HEMODIALYSIS CONCENTRATE | Dana Laboratories | 1986-01-08 |
| K852749 | RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT | Mesa Medical, Inc. | 1985-09-10 |
| K852310 | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK | Erika, Inc. | 1985-07-26 |