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U.S. Department of Health and Human Services

510(k) Premarket Notification
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91 to 100 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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510(K)
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carestart-pregnancy and carestart plus-pregnancy ACCESS BIO INCORPORATE K032159 09/05/2003
cedia vancomycin assay MICROGENICS CORP. K032811 11/24/2003
cellavision dm96 automatic hematology analyzer CELLAVISION AB K033840 02/10/2004
chemstrip 5 ob, chemstrip 7 and chemstrip 10 md test strips ROCHE DIAGNOSTICS CORP. K032437 10/08/2003
chlamydia igg elisa test system TRINITY BIOTECH USA K033079 11/26/2003
cholestech ldx aspartate aminotransferase (ast) CHOLESTECH CORP. K032027 09/05/2003
chrono-log whole blood aggregometer, models 591a and 592a CHRONO-LOG CORP. K032951 04/02/2004
clinitest hcg pregnancy test BAYER HEALTHCARE, LLC K032563 12/23/2003
co2 calibrator/diluent BAYER HEALTHCARE, DIAGNOSTICS DIVISION K033643 01/08/2004
cobas integra alp ifcc gen.2 ROCHE DIAGNOSTICS CORP. K033185 10/14/2003

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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