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FDA 510(k) Applications Submitted by INTERNATIONAL NEWTECH DEVELOPMENT, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K974009
10/21/1997
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K974059
10/27/1997
ONE STEP MIDSTREAM HCG PREGNANCY TEST
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K974060
10/27/1997
MINISTRIP/ SERUM AND URINE COMBO HCG TEST
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K993850
11/12/1999
URINALYSIS REAGENT STRIPS (10 PARAMETERS)
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K963132
08/12/1996
MINI STRIP/SERUM HCG
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K963133
08/12/1996
PS-UNIT CASSETTE/SERUM HCG
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
K970176
01/17/1997
HCG CONTROLS
INTERNATIONAL NEWTECH DEVELOPMENT, INC.
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