510(k) K071387 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB
| Applicant | Fresenius Medical Care North America, Waltham MA, US |
| Decision | Substantially Equivalent, Jun 15, 2007 |
| Received | May 18, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071387
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2015 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle
A Dialysate Concentrate for Hemodialysis (liquid)
Product Code: 08-4000-LB Open, Classified |
KPO | None listed |
| Jun 22, 2015 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle
Catalog Number: 08-4000-LB
This concentrate is formulated to be used with a three steam hem Open, Classified |
KPO | None listed |
| Sep 23, 2014 | Fresenius Medical Care Holdings, Inc. Fresenius Naturalyte Liquid Bicarbonate Concentrate
Product Number: 08-4000-LB
The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicar Terminated |
KPO | None listed |
| Jun 9, 2014 | Fresenius Medical Care Holdings, Inc. NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB.
The concentrate is formulated to be used with a three steam hemodialysis mac Terminated |
KPO | None listed |
| May 22, 2014 | Fresenius Medical Care Holdings, Inc. Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle
Part Number: 08-4000-LB
The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and b Open, Classified |
KPO | None listed |
| Jun 10, 2011 | Fresenius Medical Care Holdings, Inc. Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid
Part number: 08-4000-LB
Formulated to be used with a three stream hemodialysis machine which is calibr Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.