510(k) K070177 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Mar 29, 2007 |
| Received | Jan 18, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070177
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2022 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis. Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-1301-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3201-4 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3231-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-3301-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate bottles, Model Number 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate drums, Model Number 13-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate drums, Model Number 13-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate drums, Model Number 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Acid concentrate drums, Model Number 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Citrasate Liquid Acid concentrate bottles, Model Number 08-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Citrasate Liquid Acid concentrate drums, Model Number 13-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Acid concentrate bottles, Product Code 08-1251-1 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Acid concentrate bottles, Product Code 08-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Acid concentrate bottles, Product Code 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Acid concentrate bottles, Product Code 08-2351-8 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Acid concentrate bottles, Product Code 08-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution th Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Acid concentrate drums, Product Code 13-2251-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Acid concentrate drums, Product Code 13-3251-9 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thre Open, Classified |
KPO | None listed |
| Jan 11, 2021 | Fresenius Medical Care Holdings, Inc. Citrasate Liquid Acid concentrate drums, Product Code 13-2251 -CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution thr Open, Classified |
KPO | None listed |
| Dec 17, 2020 | Fresenius Medical Care Holdings, Inc. Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis
Part Number: 08-3251-9 Terminated |
KPO | None listed |
| May 2, 2018 | Fresenius Medical Care Renal Therapies Group, LLC NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1
Product Usage:
This concentrate is formulated to be used in conjunction with Fresenius Renal Technolog Terminated |
KPO | None listed |
| Sep 29, 2017 | Fresenius Medical Care Renal Therapies Group, LLC NaturaLyte Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0
3.43 liter bottle
This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concen Terminated |
KPO | None listed |
| Feb 25, 2016 | Fresenius Medical Care Renal Therapies Group, LLC Fresenius Naturalyte Liquid Acid Concentrate
Catalog Number: 08-2301-3
Intended Use: Acid Concentrate for Bicarbonate Dialysis Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.