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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