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 |
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 |
|
|