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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: JWY Applicant: AB BIODISK Decision Date To: 02/01/2023
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etest doripenem - antimicrobial susceptibility test - mic at 0.002-32 ug/ml AB BIODISK K081325 07/24/2008
etest tigecycline gram positive and gram negative aerobic bacteria, streptococcus spp. and anaerobic bacteria AB BIODISK K052366 10/13/2005
daptomycin AB BIODISK K042392 12/13/2004
etest for gemifloxacin AB BIODISK K042390 11/19/2004
etest cefditoren for s. pneumoniae and h. influenzae AB BIODISK K021445 06/06/2002
etest ertapenem AB BIODISK K020748 04/29/2002
etest meropenem AB BIODISK K010363 04/09/2001
etest esbl ct/ctl strip; etest esbl tz/tzl strip AB BIODISK K001547 08/07/2000
etest gatifloxacin AB BIODISK K000596 05/22/2000
etest moxifloxacin AB BIODISK K000298 05/18/2000