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U.S. Department of Health and Human Services

510(k) Premarket Notification

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ProductCode: JTN Applicant: UNIPATH LTD. Decision Date To: 09/30/2022
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aztreonam antimicrobial susceptibility test disc UNIPATH LTD. K964490 02/07/1997
cefaclor antimicrobial susceptibility test disc UNIPATH LTD. K964489 02/07/1997
cefepine antimicrobial susceptibility test disc UNIPATH LTD. K964495 02/07/1997
cefixime antimicrobial susceptibilty test disc UNIPATH LTD. K964496 02/06/1997
ceftizoxime antimicrobial susceptibility test disc UNIPATH LTD. K964512 02/06/1997
ciprofloxacin antimicrobial susceptibility test disc UNIPATH LTD. K964492 02/07/1997
imipenem antimicrobial susceptibility test disc UNIPATH LTD. K964487 02/07/1997
norfloxacin antimicrobial susceptibility test disc UNIPATH LTD. K964491 02/07/1997
ofloxacin antimicrobial susceptibility test disc UNIPATH LTD. K964493 02/06/1997
sulbactam/ampicillin antimicrobial susceptibility test disc UNIPATH LTD. K964501 02/06/1997
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