FDA 510(k) Applications for Medical Device:
Hexokinase, Glucose
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K990981 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K170316 | Abbott Laboratories |
Dept. 09AA, Bldg CP1-3, 100 Abbott Park Road | Abbott Park | IL | 60064 |
| K981185 | ABBOTT LABORATORIES |
DEPT. 09VA LC-2 | IRVING | TX | 75038 |
| K060383 | ABBOTT LABORATORIES |
1921 HURD DR. | IRVING | TX | 75038 |
| K123018 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K072140 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K113131 | AMS |
17/A VIA E. BARSANTI | GUIDONIA, ROME | I-00012 | |
| K080468 | AMS S.R.L. ANALYZER MEDICAL SYSTEM |
17/A VIA E. BARSANTI | GUIDONIA (ROME) | I-00012 | |
| K011963 | BAYER CORP. |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591-5097 |
| K964004 | BAYER CORP. |
1884 MILES AVE. | ELKHART | IN | 46515-0070 |
| K971276 | BAYER CORP. |
1884 MILES AVE. | ELKHART | IN | 46515-0070 |
| K052163 | BAYER HEALTHCARE, LLC |
511 BENEDICT AVE. | TARRYTOWN | NY | 10591 |
| K060256 | BECKMAN COULTER, INC. |
200 S. KRAEMER BLVD. | BREA | CA | 92622 |
| K131189 | BECKMAN COULTER, INC. |
250 S. KRAEMER ST | BREA | CA | 92821 |
| K971467 | CAROLINA LIQUID CHEMISTRIES CORP. |
451 WEST LAMBERT RD., | BREA | CA | 92821 |
| K980883 | CRESTAT DIAGNOSTICS, INC. |
910 INDUSTRY DR. | SEATTLE | WA | 98056 |
| K031135 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K970664 | DERMA MEDIA LAB., INC. |
8531 WELLSFORD PL., SUITE E | SANTA FE SPRINGS | CA | 90670 |
| K961282 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K023739 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN | C1E 2A6 | |
| K151487 | Diatron US, Inc. |
2304 W 78th Street | Hialeah | FL | 33016 |
| K000556 | ELAN DIAGNOSTICS |
231 NORTH PUENTE ST. | BREA | CA | 92821 |
| K153644 | ELITechGroup |
ZONE INDUSTRIELLE | Sees | 61500 | |
| K041052 | HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K012668 | HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K061879 | HEMODIAGNOSTICA, LLC |
130 GARDENERS CIRCLE | JOHNS ISLAND | SC | 29455 |
| K960084 | HI CHEM, INC. |
231 N. PUENTE ST. | BREA | CA | 92621 |
| K120369 | HITACHI CHEMICAL DIAGNOSTICS, INC. |
630 CLYDE CT. | MOUNTAIN VIEW | CA | 94043 |
| K052007 | HORIBA ABX |
PARC EUROMEDECINE | MONTPELLIER, HERAULT | 34184 | |
| K081276 | HORIBA ABX |
PARC EUROMEDECINE | MONTPELLIER | 34184 | |
| K103788 | HORIBA ABX SAS |
PARC EUROMEDECINE | MONTPELLIER | 34184 | |
| K011900 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K092506 | MEDICA CORP. |
5 OAK PARK DRIVE | BEDFORD | MA | 01730 |
| K962435 | ORASURE TECHNOLOGIES, INC. |
1745 EATON AVE. | BETHLEHEM | PA | 18018-1799 |
| K971754 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K002199 | POINTE SCIENTIFIC, INC. |
1025 JOHN A. PAPALAS DR. | LINCOLN PARK | MI | 48146 |
| K062118 | POINTE SCIENTIFIC, INC. |
5449 RESEARCH DRIVE | CANTON | MI | 48188 |
| K090703 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K020852 | POLYMEDCO, INC. |
510 FURNACE DOCK RD. | CORTLANDT MANOR | NY | 10567 |
| K953210 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | CRUMLIN | BT29 4QY | |
| K953847 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
1080 U.S. HIGHWAY 202 | BRANCHBURG | NJ | 08876-3771 |
| K092603 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K220134 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K191899 | Roche Diagnostics |
9115 Hague Road | Indianapolis | IN | 46250 |
| K061048 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K062239 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K072018 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K112377 | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
55 NORTHERN BLVD., SUITE 200 | GREAT NECK | NY | 11021 |
| K101854 | SIEMENS HEALTHCARE DIAGNOSTICS |
511 benedict Avenue | Tarrytown | NY | 10591 |
| K120681 | Siemens Healthcare Diagnostics Inc. |
511 BENEDICT AVENUE | TARRYTOWN | NY | 10509 |
| K984574 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K001403 | SIGMA DIAGNOSTICS, INC. |
545 SOUTH EWING AVE. | ST. LOUIS | MO | 63103 |
| K000102 | TECO DIAGNOSTICS |
4925 EAST HUNTER AVE. | ANAHEIM | CA | 92807 |
| K042767 | THERMO ELECTRON CORPORATION |
331 SOUTH 104TH STREET | LOUISVILLE | CO | 80027 |
| K103531 | TOKYO BOEKI MEDISYS INC. |
5105 FAIROAKS ROAD | DURHAM | NC | 27712 |
| K980026 | TRACE AMERICA, INC. |
7260 NORTH WEST 58TH ST. | MIAMI | FL | 33166 |
| K080123 | WAKO CHEMICALS USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
| K024281 | WAKO CHEMICALS, USA, INC. |
1600 BELLWOOD ROAD | RICHMOND | VA | 23237 |
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