FDA 510(k), K121710, XPERT CT/NG
FDA 510(k), K121710, XPERT CT/NG
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510(K) Number: K121710
Device Name: XPERT CT/NG
Manufacturer: RUSSEL K ENNS
Device Classification Name: Dna-Reagents, Neisseria
Regulation Number: LSL
Classification Product Code: 06/11/2012
Date Received: 12/27/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: XPERT CT/NG
Manufacturer: RUSSEL K ENNS
Device Classification Name: Dna-Reagents, Neisseria
Regulation Number: LSL
Classification Product Code: 06/11/2012
Date Received: 12/27/2012
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology