Dialysate Concentrate
FDA 510(k) K812330 · Central Biological Co.
510(k) numberK812330
Submission
- Device name
- Dialysate Concentrate
- Applicant
- Central Biological Co.
Mchenry, IL, US - Received
- August 18, 1981
- Decision date
- September 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKQ – System, Dialysate Delivery, Central Multiple Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FKQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052764 | Diacap Ultra Dialysis Fluid FilterFKQ · Traditional | B. Braun Medizintechnologie GmbH | 06/09/2006SE |
| K893612 | Two Tank Dissolution ModuleFKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 07/24/1989SE |
| K874084 | Multiple Artificial Kidney Systems (Maks) #IdmFKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 04/27/1988SE |
| K873421 | Kawasumi A.V. Fistula SetFKQ · Traditional | Kawasumi Laboratories Co., Ltd. | 10/09/1987SE |
| K870889 | Acid Fuchsin SolutionsFKQ · Traditional | D.R.G. Scientific Industries | 07/08/1987SE |
| K861730 | Actril for Kidney Machine DisinfectantFKQ · Traditional | Renal Systems, Inc. | 06/09/1987SE |
| K864635 | Four Tank Dissolution ModuleFKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 01/13/1987SE |
| K862304 | Drake Willock Central Dialysate Delivery SystemFKQ · Traditional | Cd Medical, Inc. | 09/09/1986SE |
| K861472 | Maks Central Delivery Systems Models 11-425/11-445FKQ · Traditional | National Medical Care, Medical Products Div., Inc. | 07/10/1986SE |
| K852359 | Amuchina/Dialyzer DisinfectantFKQ · Traditional | Amuchina Intl., Inc. | 05/13/1986SE |
More from Amuchina Intl., Inc.
Questions and answers
When was Dialysate Concentrate cleared by the FDA?
Dialysate Concentrate (K812330) received a 510(k) decision of Substantially Equivalent on September 29, 1981, 42 days after the submission was received.
What is the product code of K812330?
The FDA product code is FKQ – System, Dialysate Delivery, Central Multiple Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.