FDA 510(k) Applications for Medical Device:
Antisera, All Groups, Streptococcus Spp.

FDA 510(k) Number Applicant Address City / Country State / Province Postal Code
K952819 ABBOTT LABORATORIES ONE ABBOTT PARK RD.
ABBOTT PARK IL 60064-3500
K971522 ABBOTT LABORATORIES 200 ABBOTT PARK RD.
ABBOTT PARK IL 60064
K012521 BINAX, INC. 217 READ ST.
PORTLAND ME 04103
K991726 BINAX, INC. 217 READ ST.
PORTLAND ME 04103
K960712 BINAX, INC. 217 READ ST.
PORTLAND ME 04103
K010523 BINAX, INC. 217 READ ST.
PORTLAND ME 04103
K962060 BIOSTAR, INC. 6655 LOOKOUT RD.
BOULDER CO 80301
K962146 EXCEL SCIENTIFIC, INC. 23071 LA PALMA AVE.
YORBA LINDA CA 92887
K955108 QUIDEL CORP. 10165 MCKELLAR COURT
SAN DIEGO CA 92121
K011709 TRINITY BIOTECH, PLC IDA BUSINESS PARK
BRAY
K962296 UNIPATH LTD. 15 OAK ST.
BEVERLY FARMS MA 01915
K961423 WYNTEK DIAGNOSTICS, INC. 6145 NANCY RIDGE DR.
SAN DIEGO CA 92121




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