Naturalyte Bicarbonate Concentrate-Dry Pack
FDA 510(k) K852310 · Erika, Inc.
510(k) numberK852310
Submission
- Device name
- Naturalyte Bicarbonate Concentrate-Dry Pack
- Applicant
- Erika, Inc.
Rockleigh, NJ, US - Received
- May 29, 1985
- Decision date
- July 26, 1985
- 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.
| 510(k) | Device | Decision |
|---|---|---|
| K853134 | National Med Care Infusion Pump Adm Set #95-0001-8FRN · Traditional | 11/06/1985SE |
| K852309 | Erika Art Li, 3-9621-8, 22-6, 23-4 & Ven 9714-1FJK · Traditional | 07/26/1985SE |
| K850866 | Toray Industries Filtryzer Hollow Fiber Kidney B1LKDI · Traditional | 04/03/1985SE |
| K850865 | Toray Industries Filtryzer Hollow Fiber Kidney B1-FJI · Traditional | 04/03/1985SE |
| K850655 | Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2FJI · Traditional | 03/07/1985SE |
| K850654 | Toray Indus. Filtryzer Hollow Fiber Artificial KidFJI · Traditional | 03/07/1985SE |
| K842436 | Erika Negative Press. Arterial BloodKOC · Traditional | 07/13/1984SE |
| K831176 | Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional | 06/22/1984SE |
| K831175 | Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional | 06/22/1984SE |
| K831174 | Filtryzer Hollow Fiber Artificial Kid-KOC · Traditional | 06/22/1984SE |
Questions and answers
When was Naturalyte Bicarbonate Concentrate-Dry Pack cleared by the FDA?
Naturalyte Bicarbonate Concentrate-Dry Pack (K852310) received a 510(k) decision of Substantially Equivalent on July 26, 1985, 58 days after the submission was received.
What is the product code of K852310?
The FDA product code is FKQ – System, Dialysate Delivery, Central Multiple Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.