FDA 510(k) Applications for Medical Device:
Enzymatic Method, Creatinine
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K142391 | ACON LABORATORIES, INC. |
10125 MESA RIM ROAD | SAN DIEGO | CA | 92121 |
| K080073 | ALFA WASSERMANN, INC. |
4 HENDERSON DR. | WEST CALDWELL | NJ | 07006 |
| K072409 | AXIS-SHIELD POC AS |
MARSTRANDGATA 6 | RODELOKKA, OSLO | N-0504 | |
| K021428 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K091742 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD. | BREA | CA | 92822-8000 |
| K093458 | BECKMAN COULTER, INC. |
200 S. KRAEMER BOULEVARD | BREA | CA | 92822-8000 |
| K073055 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714 |
| K070383 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K030035 | DIAMETRICS MEDICAL, INC. |
2658 PATTON RD. | SAINT PAUL | MN | 55113 |
| K062105 | DIAZYME LABORATORIES |
3550 GENERAL ATOMICS CT. | SAN DIEGO | CA | 92121 |
| K132399 | ELITECH GROUP |
21720 23RD DR S.E., SUITE 150 | BOTHELL | WA | 98021 |
| K980043 | EXIGENT DIAGNOSTICS, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K182384 | Healthy.io Ltd |
2 Ibn Gabirol | Tel Aviv | 6407702 | |
| K110137 | HORIBA ABX S.A.S. |
PARC EUROMEDECINE | MONTPELLIER CEDEX 4, HERAULT | 34184 | |
| K193649 | Horiba ABX SAS |
Parc Euromedecine | Montpellier Cedex 4 | 341184 | |
| K183555 | Instrumentation Laboratory Co. |
180 Hartwell Road | Bedford | MA | 01730 |
| K984530 | METRIKA, INC. |
575 Shirlynn Court | Los Altos | CA | 94022 |
| K001310 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K182063 | Ortho-Clinical Diagnostics, Inc. |
100 Indigo Creek Drive | Rochester | NY | 14626 |
| K063591 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DRIVE | ROCHESTER | NY | 14626-5101 |
| K071216 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K071215 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K061944 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K010456 | POLYMER TECHNOLOGY SYSTEMS, INC. |
7736 ZIONSVILLE RD. | INDIANAPOLIS | IN | 46268 |
| K024098 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K003261 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K073634 | SENTINEL CH. SpA |
Via Robert Koch, 2 | Milano | 20152 | |
| K103376 | SEPPIM S.A.S. |
21720 23RD DR SE | BOTHELL | WA | 98021 |
| K212223 | Siemens Healthcare Diagnostics Inc. |
511 Benedict Avenue | Tarrytown | NY | 10591 |
| K090330 | Siemens Healthcare Diagnostics Inc. |
PO BOX 6101 | NEWARK | DE | 19714-6101 |
| K070727 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K050283 | STANBIO LABORATORY |
1261 NORTH MAIN ST. | BOERNE | TX | 78006 |
| K161527 | TECO DIAGNOSTICS, INC. |
1268 NORTH LAKEVIEW AVENUE | ANAHEIM | CA | 92807 |
| K152835 | TECO DIAGNOSTICS, INC. |
1268 N. LAKEVIEW AVE. | ANAHEIM | CA | 92807 |
| K061412 | THERMO ELECTRON CORP. |
171 INDUSTRY DRIVE | PITTSBURG | PA | 15272 |
| K070824 | THERMO FISHER SCIENTIFIC OY |
2 RATASTIE | VANTAA | 01620 | |
| K061775 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K012065 | WIENER LABORATORIES S.A.I.C. |
2944 RIOBAMBA | ROSARIO | 2000 | |
| K182038 | YD Diagnostics Corporation |
76, Seori-ro, Idong-myeon, Cheoin-gu | Yongin-si | 17127 |
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