FDA 510(k) Applications for Medical Device:
Antigens, All Groups, Streptococcus Spp.
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K010582 |
ACON LABORATORIES CO. |
4108 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K023766 |
ACON LABORATORIES CO. |
4108 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K031784 |
ACON LABORATORIES, INC. |
4108 SORRENTO VALLEY BLVD.
| SAN DIEGO |
CA |
92121 |
K122718 |
Becton, Dickinson and Company |
10865 ROAD TO THE CURE,
| SAN DIEGO |
CA |
92121 |
K091489 |
BINAX, INC. |
10 SOUTHGATE RD.
| SCARBOROUGH |
ME |
04074 |
K991828 |
BIOSTAR, INC. |
6655 LOOKOUT RD.
| BOULDER |
CO |
80301 |
K133343 |
Guangzhou Wondfo Biotech Co., Ltd. |
504 EAST DIAMOND AVE.
| GAITHERSBURG |
MD |
20878 |
K212623 |
Healgen Scientific, LLC |
5213 Maple St
| Bellaire |
TX |
77401 |
K971349 |
PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1
| MONMOUTH JUNCTION |
NJ |
08852-1905 |
K983386 |
PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1
| MONMOUTH JUNCTION |
NJ |
08852-1905 |
K082661 |
PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1
| MONMOUTH JUNCTION |
NJ |
08852-1905 |
K040708 |
PRINCETON BIOMEDITECH CORP. |
4242 U.S. RT. 1
| MONMOUTH JUNCTION |
NJ |
08852-1905 |
K011097 |
QUIDEL CORP. |
10165 MCKELLAR CT.
| SAN DIEGO |
CA |
92121 |
K141775 |
QUIDEL CORPORATION |
12544 HIGH BLUFF (ADMINISTRATIVE OFFICE LOCATION)
| SAN DIEGO |
CA |
92130 |
K123793 |
QUIDEL CORPORATION |
10165 MCKELLAR COURT
| SAN DIEGO |
CA |
92121 |
K171976 |
Quidel Corporation |
12544 High Bluff Drive, Suite 200
| San Diego |
CA |
92130 |
K993456 |
SA SCIENTIFIC, INC. |
4919 GOLDEN QUAIL
| SAN ANTONIO |
TX |
78240 |
K013379 |
SA SCIENTIFIC, INC. |
4919 GOLDEN QUAIL
| SAN ANTONIO |
TX |
78240 |
K023270 |
SA SCIENTIFIC, INC. |
4919 GOLDEN QUAIL
| SAN ANTONIO |
TX |
78240 |
K982373 |
TRINITY BIOTECH, PLC |
575 Shirlynn Court
| Los Altos |
CA |
94022 |
K051638 |
UNIPATH LTD. |
PRIORY BUSINESS PARK
| BEDFORD |
|
MK44 3UP |
K992658 |
WYNTEK DIAGNOSTICS, INC. |
6146 NANCY RIDGE DR.,
| SAN DIEGO |
CA |
92121 |
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