FDA 510(k) Applications for Medical Device:
Campylobacter Pylori
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K982362 | ABBOTT LABORATORIES |
200 ABBOTT PARK RD. | ABBOTT PARK | IL | 60064 |
| K024350 | ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD. | SAN DIEGO | CA | 92121 |
| K151935 | ALERE SAN DIEGO, INCORPORATED |
9975 SUMMERS RIDGE ROAD | SAN DIEGO | CA | 92121 |
| K024360 | ALFA SCIENTIFIC DESIGNS, INC. |
12330 STOWE DR. | POWAY | CA | 92064 |
| K981396 | AMDL, INC. |
14272 FRANKLIN AVE., #106 | TUSTIN | CA | 92680-7017 |
| K052708 | ARJ MEDICAL, INC. |
209 STATE STREET | OLDSMAR | FL | 34677 |
| K961221 | ARMKEL, LLC. |
1306F BAILES LN. | FREDERICK | MD | 21701 |
| K041238 | BIOHIT PLC |
3535 ROUTE 66 | NEPTUNE | NJ | 07753 |
| K141133 | BIOMERIEUX |
595 ANGLUM ROAD | HAZELWOOD | MO | 63042-2320 |
| K001460 | BIOMERIEUX, INC. |
1022 HINGHAM ST. | ROCKLAND | MA | 02370 |
| K973523 | BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. | INDIANAPOLIS | IN | 46250-0457 |
| K960478 | CHEMTRAK, INC. |
929 E. ARQUES AVE. | SUNNYVALE | CA | 94086 |
| K965099 | CHEMTRAK, INC. |
929 EAST ARQUES AVE. | SUNNYVALE | CA | 94086-4520 |
| K990462 | COLUMBIA BIOSCIENCE, INC. |
8775 M CENTRE PARK DR. | COLUMBIA | MD | 21045 |
| K972146 | CONSOLIDATED TECHNOLOGIES, INC. |
2170 WOODWARD STREET, STE. 100 | AUSTIN | TX | 78744-1832 |
| K953686 | CORTECS, LTD. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
| K000463 | DIAGNOSTIC PRODUCTS CORP. |
5700 WEST 96TH ST. | LOS ANGELES | CA | 90045-5597 |
| K181464 | DiaSorin Inc. |
1951 Northwestern Ave. | Stillwater | MN | 55082-0285 |
| K161139 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082-0285 |
| K954926 | E-Z-EM, INC. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
| K953873 | ELIAS USA, INC. |
373 280TH ST. | OSCEOLA | WI | 54020 |
| K001177 | ENTERIC PRODUCTS, INC. |
25 EAST LOOP DR. | STONY BROOK | NY | 11790 |
| K984544 | ENTERIC PRODUCTS, INC. |
25 EAST LOOP DR. | STONY BROOK | NY | 11790 |
| K012411 | GI SUPPLY |
200 GRANDVIEW AVE. | CAMP HILL | PA | 17011 |
| K110899 | GOLD STANDARD DIAGNOSTICS |
2851 SPAFFORD | Davis | CA | 95618 |
| K110745 | GOLD STANDARD DIAGNOSTICS |
2851 SPAFFORD | Davis | CA | 95618 |
| K982790 | INOVA DIAGNOSTICS, INC. |
10180 SCRIPPS RANCH BLVD. | SAN DIEGO | CA | 92131 |
| K024334 | INOVA DIAGNOSTICS, INC. |
10180 SCRIPPS RANCH BLVD. | SAN DIEGO | CA | 92131 |
| K964014 | KENLOR INDUSTRIES, INC. |
1560 EAST EDINGER AVE., | SANTA ANA | CA | 92705 |
| K991248 | MEDICAL INSTRUMENTS CORPORATION MIC AG |
FRIEDHOFPLATZ 16 | SOLOTHURN | 4502 | |
| K002451 | MEDICAL INSTRUMENTS CORPORATION, AG |
POB 706 CH-4502 | SOLOTHURN | CH-4502 | |
| K002023 | MEDMIRA LABORATORIES, INC. |
155 CHAIN LAKE DR. | HALIFAX, N.S. | B3S 1B3 | |
| K952220 | MERETEK DIAGNOSTICS, INC. |
1709 DRYDEN RD. | HOUSTON | TX | 77030 |
| K153661 | Meridian Bioscience, Inc |
3471 River Hills Drive | Cincinnati | OH | 45244 |
| K192817 | Meridian Bioscience, Inc. |
3471 River Hills Drive | Cincinnati | OH | 45244 |
| K032222 | MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K230901 | Meridian Bioscience, Inc. |
3471 River Hills Drive | Cincinnati | OH | 45244 |
| K182559 | Meridian Bioscience, Inc. |
3471 River Hills Drive | Cincinnati | OH | 45244 |
| K053335 | MERIDIAN BIOSCIENCE, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K961508 | MERIDIAN DIAGNOSTICS, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K983255 | MERIDIAN DIAGNOSTICS, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K980076 | MERIDIAN DIAGNOSTICS, INC. |
3471 RIVER HILLS DR. | CINCINNATI | OH | 45244 |
| K003794 | MICRO DETECT, INC. |
2852 WALNUT AVE., SUITE H-1 | TUSTIN | CA | 92780 |
| K973508 | MICRO DETECT, INC. |
23016 DEL LAGO DR., SUITE B | LAGUNA HILLS | CA | 92653 |
| K022356 | NICHOLS INSTITUTE DIAGNOSTICS |
1311 CALLE BATIDO | SAN CLEMENTE | CA | 92673 |
| K971537 | ORION DIAGNOSTICA, DIV. ORION CORP. |
KOIVUMANKKAANTIE 6 | ESPOO | 02200 | |
| K052716 | OTSUKA PHARMACEUTICAL CO., LTD. |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K012588 | OXOID, LTD. |
WADE RD. | BASINGSTOKE, HAMPSHIRE | RG24 8PW | |
| K183573 | Panion & BF Biotech Inc. |
6F.-3, No.306, Sec. 1, Datong Rd., Xizhi Dist. | New Taipei City | 22146 | |
| K980798 | PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1 | MONMOUTH JUNCTION | NJ | 08852-1905 |
| K964675 | PYRAMID BIOLOGICAL CORP. |
6454 VAN NUYS BLVD., SUITE 111 | VAN NUYS | CA | 91401 |
| K991747 | QUIDEL CORP. |
10165 MCKELLAR CT. | SAN DIEGO | CA | 92121 |
| K952517 | QUIDEL CORP. |
10165 MCKELLAR COURT | SAN DIEGO | CA | 92121 |
| K980782 | SALIVA DIAGNOSTIC SYSTEMS, INC. |
11719 NE 95TH ST. | VANCOUVER | WA | 98682 |
| K955085 | SCHIFF & CO. |
1129 BLOOMFIELD AVE. | WEST CALDWELL | NJ | 07006 |
| K014038 | SERIM RESEARCH CORP. |
23565 REEDY DR. | ELKHART | IN | 46514 |
| K972981 | SHIELD DIAGNOSTICS, LTD. |
THE TECHNOLOGY PARK | DUNDEE | DD2 1SW | |
| K960183 | SMITH KLINE DIAGNOSTICS, INC. |
225 BAYPOINTE PKWY. | SAN JOSE | CA | 95134-1622 |
| K181400 | TECHLAB, Inc. |
2001 Kraft Drive | Blacksburg | VA | 24060 |
| K181379 | TECHLAB, Inc. |
2001 Kraft Drive | Blacksburg | VA | 24060-6358 |
| K033067 | TRINITY BIOTECH USA |
P.O. BOX 1059 | JAMESTOWN | NY | 14702-1059 |
| K991697 | TRINITY BIOTECH, PLC |
575 Shirlynn Court | Los Altos | CA | 94022 |
| K980821 | ZEUS SCIENTIFIC, INC. |
P.O. BOX 38 | RARITAN | NJ | 08869 |
| K991820 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
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