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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 20 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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a1cnow for home and professional use METRIKA, INC. K033847 12/23/2003
abbott architect estradiol calibrators; abbott imx estradiol calibrator; abbott imx estradiol mode 1 calibrator; abbott ABBOTT LABORATORIES K032458 10/06/2003
abbott axsym b-type natriuretic peptide (bnp) microparticle enzyme immunoassay (meia) test AXIS-SHIELD DIAGNOSTICS, LTD. K033606 01/30/2004
access immunoassay system toxo igg assay BECKMAN COULTER, INC. K032162 08/08/2003
accu-chek advantage system ROCHE DIAGNOSTICS CORP. K032552 09/12/2003
accubind neonatal t4 microplate eia, model 2625-300 MONOBIND K030860 08/22/2003
accutest hcg-combo model,hcg-004, accustrip hcg-combo model, hcg-005 UNOTECH DIAGNOSTICS, INC. K032987 11/17/2003
acis (automated cellular imaging system) CHROMA VISION MEDICAL SYSTEMS INC. K032113 12/23/2003
acl top model, top INSTRUMENTATION LABORATORY CO. K033414 01/12/2004
acon coc-150 one step cocaine test strip & acon coc-150 one step cocaine test device ACON LABORATORIES, INC. K032903 02/17/2004

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