FDA 510(k) Applications for Medical Device:
Reagent, Borrelia Serological Reagent
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K080012 | BIO-RAD |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K081362 | BIO-RAD |
163 CABOT ST. | BEVERLY | MA | 01915 |
| K183446 | Bio-Rad Laboratories |
5500 East Second Street | Benicia | CA | 94510 |
| K122986 | BIOMERIEUX SA |
CHEMIN DE L ORME | MARCY L ETOILE | 69280 | |
| K122979 | BIOMERIEUX SA |
CHEMIN DE L ORME | MARCY L ETOILE | 69280 | |
| K974809 | BOSTON BIOMEDICA, INC. |
375 WEST ST. | WEST BRIDGEWATER | MA | 02379 |
| K974810 | BOSTON BIOMEDICA, INC. |
375 WEST ST. | WEST BRIDGEWATER | MA | 02379 |
| K980351 | BOSTON BIOMEDICA, INC. |
375 WEST ST. | WEST BRIDGEWATER | MA | 02379 |
| K032713 | BOSTON BIOMEDICA, INC. |
375 WEST ST. | WEST BRIDGEWATER | MA | 02379 |
| K971169 | CAMBRIDGE BIOTECH CORP. |
1500 EAST GUDE DR. | ROCKVILLE | MD | 20850-5307 |
| K971170 | CAMBRIDGE BIOTECH CORP. |
1500 EAST GUDE DR. | ROCKVILLE | MD | 20850-5307 |
| K970768 | CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
MERVUE BUSINESS PARK | GALWAY | ||
| K970761 | CAMBRIDGE DIAGNOSTICS IRELAND, LTD. |
MERVUE BUSINESS PARK | GALWAY | ||
| K981913 | Chembio Diagnostic Systems, Inc. |
25 EAST LOOP RD. | STONEYBROOK | NY | 11790 |
| K983605 | COLUMBIA BIOSCIENCE, INC. |
8775 M CENTRE PARK DR. | COLUMBIA | MD | 21045 |
| K983606 | COLUMBIA BIOSCIENCE, INC. |
8775 M CENTRE PARK DR. | COLUMBIA | MD | 21045 |
| K202574 | DiaSorin Inc. |
1951 Northwestern Avenue | Stillwater | MN | 55082 |
| K202573 | DiaSorin Inc. |
1951 Northwestern Avenue | Stillwater | MN | 55082 |
| K193051 | DiaSorin Inc. |
1951 Northwestern Ave | Stillwater | MN | 55082-0285 |
| K062473 | DIASORIN, INC. |
1951 NORTHWESTERN AVE. | STILLWATER | MN | 55082 |
| K161513 | EUROIMMUN US |
1100 THE AMERICAN ROAD | MORRIS PLAINS | NJ | 07950 |
| K142038 | EUROIMMUN US |
1100 THE AMERICAN ROAD | MORRIS PLAINS | NJ | 07950 |
| K172722 | EUROIMMUN US, Inc. |
1 Bloomfield Ave. | Mountain Lakes | NJ | 07046 |
| K953682 | GenBio |
15222 AVE. OF SCIENCE, SUITE A | SAN DIEGO | CA | 92128 |
| K953683 | GenBio |
15222 AVE. OF SCIENCE, SUITE A | SAN DIEGO | CA | 92128 |
| K113847 | GOLD STANDARD DIAGNOSTICS |
2851 SPAFFORD | Davis | CA | 95618 |
| K113846 | GOLD STANDARD DIAGNOSTICS |
2851 SPAFFORD | Davis | CA | 95618 |
| K200025 | Gold Standard Diagnostics |
2851 Spafford St. | Davis | CA | 95618 |
| K203296 | Gold Standard Diagnostics |
2851 Spafford St. | Davis | CA | 95618 |
| K180264 | Gold Standard Diagnostics |
2851 Spafford St. | Davis | CA | 95618 |
| K203292 | Gold Standard Diagnostics |
2851 Spafford St. | Davis | CA | 95618 |
| K200023 | Gold Standard Diagnostics |
2851 Spafford St. | Davis | CA | 95618 |
| K203295 | Gold Standard Diagnostics |
2851 Spafford St. | Davis | CA | 95618 |
| K203289 | Gold Standard Diagnostics |
2851 Spafford St. | Davis | CA | 95618 |
| K233367 | ID-FISH Technology, Inc. |
556 Gibraltar Drive | Milpitas | CA | 95035 |
| K242872 | ID-FISH Technology, Inc. |
556 Gibraltar Drive | Milpitas | CA | 95035 |
| K003754 | IMMUNETICS, INC. |
63 ROGERS ST. | CAMBRIDGE, | MA | 02142 |
| K991063 | IMMUNETICS, INC. |
63 ROGERS ST. | CAMBRIDGE, | MA | 02142 |
| K991062 | IMMUNETICS, INC. |
63 ROGERS ST. | CAMBRIDGE, | MA | 02142 |
| K994004 | INOVA DIAGNOSTICS, INC. |
10180 SCRIPPS RANCH BLVD. | SAN DIEGO | CA | 92131 |
| K984222 | INOVA DIAGNOSTICS, INC. |
10180 SCRIPPS RANCH BLVD. | SAN DIEGO | CA | 92131 |
| K984234 | INOVA DIAGNOSTICS, INC. |
10180 SCRIPPS RANCH BLVD. | SAN DIEGO | CA | 92131 |
| K950829 | MARDX DIAGNOSTICS, INC. |
5919 FARNSWORTH CT. | CARLSBAD | CA | 92008 |
| K951709 | MARDX DIAGNOSTICS, INC. |
5919 FARNSWORTH CT. | CARLSBAD | CA | 92008 |
| K971006 | MRL DIAGNOSTICS |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K971007 | MRL DIAGNOSTICS |
10703 PROGRESS WAY | CYPRESS | CA | 90630-4737 |
| K173496 | Quidel Corporation |
12544 High Bluff Drive, Suite 200 | San Diego | CA | 92130 |
| K173691 | Quidel Corporation |
12544 High Bluff Drive, Suite 200 | San Diego | CA | 92130 |
| K163713 | Quidel Corporation |
12544 High Bluff Drive, Suite 200 | San Diego | CA | 92130 |
| K163095 | Trinity Biotech |
60 Pineview Dr. | Buffalo | NY | 14031 |
| K172254 | Trinity Biotech |
60 Pineview Dr. | Buffalo | NY | 14031 |
| K033083 | TRINITY BIOTECH USA |
P.O. BOX 1059 | JAMESTOWN | NY | 14702-1059 |
| K033070 | TRINITY BIOTECH USA |
P.O. BOX 1059 | JAMESTOWN | NY | 14702-1059 |
| K051169 | VIRAMED BIOTECH AG |
1730 SOUTH DITMAR STREET | OCEANSIDE | CA | 92054 |
| K163504 | VIRAMED BIOTECH AG |
BEHRINGSTRASSE 11 | PLANEGG | 82152 | |
| K163695 | Viramed Biotech AG |
Behringstrasse 11 | Planegg | 82152 | |
| K092693 | VIRAMED BIOTECH AG |
1730 SOUTH DITMAR STREET | OCEANSIDE | CA | 92054 |
| K082329 | VIRAMED BIOTECH AG |
1730 SOUTH DITMAR STREET | OCEANSIDE | CA | 92054 |
| K051071 | VIRAMED BIOTECH AG |
1730 SOUTH DITMAR STREET | OCEANSIDE | CA | 92054 |
| K220016 | Viramed Biotech AG |
Behringstrasse 11 | Planegg | 82152 | |
| K965131 | WAMPOLE LABORATORIES |
DIV. OF CARTER-WALLACE, INC. | CRANBURY | NJ | 08512 |
| K965129 | WAMPOLE LABORATORIES |
DIV. OF CARTER-WALLACE, INC. | CRANBURY | NJ | 08512 |
| K230863 | ZEUS Scientific |
200 Evans Way | Branchburg | NJ | 08876 |
| K191398 | ZEUS Scientific Inc. |
P.O. BOX 38 | Raritan | NJ | 08869 |
| K191240 | ZEUS Scientific Inc. |
P.O. BOX 38 | Raritan | NJ | 08869 |
| K984138 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K100728 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K991180 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K991185 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K113397 | ZEUS SCIENTIFIC, INC. |
200 EVANS WAY | BRANCHBURG | NJ | 08876 |
| K190907 | ZEUS Scientific, Inc. |
P.O. Box 38 | Raritan | NJ | 08869 |
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