FDA 510(k) Applications for Medical Device:
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K010760 | ADVANCED RENAL TECHNOLOGIES, INC. |
11838 N.E. 112TH ST. | KIRKLAND | WA | 98033 |
| K000792 | ADVANCED RENAL TECHNOLOGIES, INC. |
11838 N.E. 112TH ST. | KIRKLAND | WA | 98033 |
| K980659 | ADVANCED RENAL TECHNOLOGIES, INC. |
2151 NORTH NORTHLAKE WAY, #200 | SEATTLE | WA | 98103 |
| K990507 | ALTHIN BIOPHARM, INC. |
3885 INDUSTRIAL BLVD. | LAVAL, QUEBEC | H7L 4S3 | |
| K990010 | ALTHIN MEDICAL AB |
BOX 39, (FRIDHEMSV. 15) | 372 21 RONNEBY | 372 21 | |
| K102194 | B. BRAUN AVITUM AG |
901 MARCON BLVD. | ALLENTOWN | PA | 18109 |
| K041683 | B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. | ALLENTOWN | PA | 18109-9341 |
| K052393 | B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. | ALLENTOWN | PA | 18109-9341 |
| K034066 | B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. | ALLENTOWN | PA | 18109 |
| K072760 | B. BRAUN MEDIZINTECHNOLOGIE GMBH |
901 MARCON BOULEVARD | ALLENTOWN | PA | 18109-9341 |
| K041428 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN RD., MPR-A2E | MCGAW PARK | IL | 60085-6730 |
| K090002 | BAXTER HEALTHCARE CORP. |
1620 WAUKEGAN ROAD | MCGAW PARK | IL | 60085 |
| K162887 | Baxter Healthcare Corporation |
32650 North Wilson Road | Round Lake | IL | 60073 |
| K240920 | DEKA Research and Development |
340 Commercial Street | Manchester | NH | 03101 |
| K171015 | Di-Chem, Inc. |
12297 Ensign Avenue North | Champlin | MN | 55316 |
| K202508 | Di-Chem, Inc. |
12297 Ensigh Avenue North | Champlin | MN | 55316 |
| K012328 | DI-CHEM, INC. |
12297 ENSIGN AVE. NORTH | CHAMPLIN | MN | 55316 |
| K012547 | DI-CHEM, INC. |
12297 ENSIGN AVE. NORTH | CHAMPLIN | MN | 55316 |
| K131202 | DIALYSIS MEDICAL SOLUTIONS, LLC |
21 EAST STATE STREET | COLUMBUS | OH | 43215 |
| K050827 | DIALYSIS SOLUTIONS, INC. |
616 HEATHROW DRIVE | LINCOLNSHIRE | IL | 60069 |
| K130511 | DIASOL, INC. |
1110 Arroyo St | San Fernando | CA | 91340 |
| K020231 | DIASOL, INC. |
13212 RAYMER ST. | NORTH HOLLYWOOD | CA | 91605 |
| K020230 | DIASOL, INC. |
13212 RAYMER ST. | NORTH HOLLYWOOD | CA | 91605 |
| K993212 | DIASOL, INC. |
13212 RAYMER ST. | NORTH HOLLYWOOD | CA | 91605 |
| K171750 | Dimesol USA, LLC |
509 Fishing Creek Road | Lewisberry | PA | 17339 |
| K030497 | FRESENIUS MEDICAL CARE |
95 HAYDEN AVE. | LEXINGTON | MA | 02420 |
| K131611 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER ST | WALTHAM | MA | 02451 |
| K070177 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 WINTER ST. | WALTHAM | MA | 02451 |
| K071387 | FRESENIUS MEDICAL CARE NORTH AMERICA |
920 Winter Street | Waltham | MA | 02451 |
| K162716 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
920 WINTER STREET | WALTHAM | MA | 02451 |
| K243786 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K192209 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K192017 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K212620 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K191474 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K233950 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K233159 | Fresenius Medical Care Renal Therapies Group, LLC |
920 Winter Street | Waltham | MA | 02451 |
| K013724 | GAMBRO RENAL PRODUCTS |
1845 MASON AVE. | DAYTONA BEACH | FL | 32117-5102 |
| K011368 | GAMBRO RENAL PRODUCTS |
1845 MASON AVE. | DAYTONA BEACH | FL | 32117-5102 |
| K052253 | GAMBRO RENAL PRODUCTS |
1845 MASON AVE. | DAYTONA BEACH | FL | 32117-5102 |
| K013448 | GAMBRO RENAL PRODUCTS |
1845 MASON AVE. | DAYTONA BEACH | FL | 32117-5102 |
| K120333 | GAMBRO RENAL PRODUCTS |
1845 MASON AVE. | DAYTONA BEACH | FL | 32117-5102 |
| K072908 | GAMBRO RENAL PRODUCTS |
1845 MASON AVE. | DAYTONA BEACH | FL | 32117-5102 |
| K180679 | Global Scientific Technologies, LLC |
151 Old Jones Road | Greer | SC | 29651 |
| K212052 | Haemopharm Biofluids S.r.l. |
Via dell'Industria 6 | Tovo di S. Agata | 23030 | |
| K150966 | HAEMOPHARM BIOFLUIDS SRL |
VIA DELL'INDUSTRIA 6 | TOVO S. AGATA | 23030 | |
| K973253 | INTERNATIONAL MEDICAL PRODUCTS, INC. |
7307 GLOUCHESTER DR. | EDINA | MN | 55435 |
| K981003 | INTERNATIONAL MEDICAL PRODUCTS, INC. |
7307 GLOUCHESTER DR. | EDINA | MN | 55435 |
| K971053 | INTERNATIONAL MEDICAL PRODUCTS, INC. |
4503 MOORLAND AVE. | MINNEAPOLIS | MN | 55435 |
| K120005 | ISOPURE CORP. |
141 CITIZENS BLVD. | SIMPSONVILLE | KY | 40067-6548 |
| K191093 | Isopure, Corp. |
11851 Plantside Drive | Louisville | KY | 40299 |
| K982813 | KAYBATH, INC. |
95-547 UKEE STREET, #110 | WAIPAHU | HI | 96797 |
| K223431 | Nipro Renal Solutions USA, Corp. |
509 Fishing Creek Road | Lewisberry | PA | 17339 |
| K193155 | Nipro Renal Solutions USA, Corp. |
509 Fishing Creek Road | Lewisberry | PA | 17339 |
| K001059 | NOVEX PHARMA |
380 ELGIN MILLS ROAD EAST | RICHMOND HILL, ONTARIO | L4C 5H2 | |
| K053286 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST., 5TH FLOOR | LAWRENCE | MA | 01843 |
| K013655 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. | S. LAWRENCE | MA | 01843 |
| K022913 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. | LAWRENCE | MA | 01843 |
| K233213 | NxStage Medical, Inc. |
350 Merrimack Street | Lawrence | MA | 01843 |
| K033386 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST. | LAWRENCE | MA | 01843 |
| K042045 | NXSTAGE MEDICAL, INC. |
439 SOUTH UNION ST.,STE 501 | LAWRENCE | MA | 01843 |
| K221652 | Renal Care Dialysis Solutions, S.A. DE C.V. |
Carretera a los Cues K.M. 2.2, Lote 23, Bodegas 5 y 6, | El Marques | 76246 | |
| K160847 | ROCKWELL MEDICAL |
30142 WIXOM ROAD | WIXOM | MI | 48393 |
| K954527 | ROCKWELL MEDICAL SUPPLY |
28025 OAKLAND OAKS CT. | WIXOM | MI | 48393 |
| K023985 | ROCKWELL MEDICAL TECHNOLOGIES, INC. |
30142 WIXOM RD. | WIXOM | MI | 48393 |
| K022521 | ROCKWELL MEDICAL TECHNOLOGIES, INC. |
30142 WIXOM RD. | WIXOM | MI | 48393 |
| K022500 | ROCKWELL MEDICAL TECHNOLOGIES, INC. |
30142 WIXOM RD. | WIXOM | MI | 48393 |
| K983618 | ROCKWELL MEDICAL TECHNOLOGIES, INC. |
28025 OAKLAND OAKS CT. | WIXOM | MI | 48393 |
| K062399 | ROCKWELL MEDICAL TECHNOLOGIES, INC. |
30142 WIXOM RD. | WIXOM | MI | 48393 |
| K981043 | SOLUTION TECHNOLOGIES |
4825 SOUTH 850 EAST | SOUTH OGDEN | UT | 84403 |
| K982378 | SOLUTION TECHNOLOGIES |
4825 SOUTH 850 EAST | SOUTH OGDEN | UT | 84403 |
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