FDA 510(k) Applications for Medical Device:
Enzymatic, Carbon-Dioxide
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K991108 | A.P. TOTAL CARE, INC. |
70 HAWLEY AVE, | BRIDGEPORT | CT | |
| K060295 | ABBOTT LABORATORIES |
1921 HURD DR. | IRVING | TX | 75038 |
| K981840 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K981231 | ABBOTT MFG., INC. |
1920 HURD DR. | IRVING | TX | 75038 |
| K113435 | ALFA WASSERMANN |
4 Henderson Drive | Caldwell | NJ | 07006 |
| K123953 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K073223 | ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
4 HENDERSON DRIVE | WEST CALDWELL | NJ | 07006 |
| K131546 | BECKMAN COULTER IRELAND INC |
250 S. KRAEMER BLVD. E1.SE.01 | BREA | CA | 92821 |
| K091153 | BECKMAN COULTER, INC. |
200 SOUTH KRAEMER BLVD. | BREA | CA | 92822 |
| K992475 | CARESIDE, INC. |
6100 BRISTOL PKWY. | CULVER CITY | CA | 90230 |
| K010206 | DADE BEHRING, INC. |
GLASCO B500 M.S. 514 | NEWARK | DE | 19714-6101 |
| K061238 | DADE BEHRING, INC. |
P.O. BOX 6101 | NEWARK | DE | 19714-6101 |
| K955302 | DATA MEDICAL ASSOCIATES, INC. |
845 AVENUE G EAST | ARLINGTON | TX | 76011 |
| K990754 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN | C1E 2A6 | |
| K002354 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN | C1E 2A6 | |
| K983019 | DIAGNOSTIC CHEMICALS LTD. |
WEST ROYALTY INDUSTRIAL PARK, | CHARLOTTETOWN, P.E.I. | C1E 2A6 | |
| K042362 | DIAGNOSTIC CHEMICALS LTD. |
16 MCCARVILLE ST. | CHARLOTTETOWN | C1E 2A6 | |
| K060619 | DIAZYME LABORATORIES |
3550 GENERAL ATOMICS CT. | SAN DIEGO | CA | 92121 |
| K111960 | ELITECHGROUP |
21720 23RD DR SE | BOTHELL | WA | 98021 |
| K010864 | HEMAGEN DIAGNOSTICS, INC. |
9033 RED BRANCH RD. | COLUMBIA | MD | 21045 |
| K140248 | HITACHI CHEMICAL DIAGNOSTICS, INC. |
575 Shirlynn Court | Los Altos | CA | 94022 |
| K012332 | JAS Diagnostics, Inc. |
7220 NW 58TH ST. | MIAMI | FL | 33166 |
| K001133 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K093611 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K120765 | Ortho-Clinical Diagnostics, Inc. |
100 INDIGO CREEK DR. | ROCHESTER | NY | 14626-5101 |
| K070251 | POINTE SCIENTIFIC, INC. |
5449 RESEARCH DRIVE | CANTON | MI | 48188 |
| K152085 | RANDOX LABORATORIES LTD |
55 DIAMOND ROAD | ARDMORE | BT29 4QY | |
| K951221 | RANDOX LABORATORIES, LTD. |
ARDMORE, DIAMOND ROAD | ANTRIM, N. IRELAND | ||
| K982056 | REAGENTS APPLICATIONS, INC. |
8225 MERCURY CT. | SAN DIEGO | CA | 92111-1203 |
| K980996 | ROCHE DIAGNOSTIC SYSTEMS, INC. |
BRANCHBURG TOWNSHIP | SOMERVILLE | NJ | 08876-3771 |
| K031879 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K032377 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250 |
| K100289 | SIEMENS HEALTHCARE DIAGNOSTICS |
333 Coney Street | Walpole | MA | 02032 |
| K960793 | SYNERMED, INC. |
1688 50TH AVENUE, | QUEBEC, CANADA | H8T 2V5 | |
| K170200 | Teco Diagnostics, Inc. |
1268 North Lakeview Avenue | Anaheim | CA | 92807 |
| K071340 | THERMO FISHER SCIENTIFIC OY |
2 RATASTIE | VANTAA | 01620 | |
| K960035 | TRACE AMERICA, INC. |
7260 NORTH WEST 58TH ST. | MIAMI | FL | 33166 |
| K100060 | VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD |
189-199 BROWNS RD | NOBLE PARK, VICTORIA | 3174 |
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