JWZ · Class I · 21 CFR 866.2660

FDA Product Code JWZ: Kit, Screening, Trichomonas

Leading manufacturers include Mercia Diagnostics , Ltd., Meridian Diagnostics, Inc. and Genzyme Corp..

11
Total
11
Cleared
105d
Avg days
1983
Since

FDA 510(k) Cleared Kit, Screening, Trichomonas Devices (Product Code JWZ)

11 devices
1–11 of 11
Cleared Apr 02, 2004
GENZYME OSOM TRICHOMONAS RAPID TEST
K033864
Genzyme Corp.
Microbiology · 112d
Cleared Aug 15, 1989
MERIVIEW TM TRICHOMONAS
K894246
Meridian Diagnostics, Inc.
Microbiology · 55d
Cleared Jun 13, 1989
SUPER DUO
K892802
Mercia Diagnostics , Ltd.
Microbiology · 57d
Cleared May 24, 1989
MERIFLUOR(TM) -TRICHOMONAS
K892263
Meridian Diagnostics, Inc.
Microbiology · 50d
Cleared May 13, 1988
TRICHOMATE(R) SUPER
K875138
Mercia Diagnostics , Ltd.
Microbiology · 150d
Cleared Aug 13, 1985
SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY
K852665
Syncor Intl. Corp.
Microbiology · 50d

About Product Code JWZ - Regulatory Context