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GNM — Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 Class I

FDA Device Classification

Classification Details

Product Code
GNM
Device Class
Class I
Regulation Number
866.3145
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K936253light diagnosticsCOXSACKIEVIRUS B4 MONOCLONAL ANTIBODYSeptember 8, 1995
K936254light diagnosticsCOCKSACKIEVIRUS B6 MONOCLONAL ANTIBODYSeptember 8, 1995
K936089chemicon intlCOXSACKIE A24 VIRUS MONOCLONAL ANTIBODYSeptember 8, 1995
K936073chemicon intlENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUSSeptember 8, 1995
K936145chemicon intlCOXSACKIEVIRUS B1 MONOCLONAL ANTIBODYSeptember 8, 1995
K936252light diagnosticsCOXSACKIEVIRUS B@ MONOCLONAL ANTIBODYSeptember 8, 1995
K940471chemicon intlCOXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIESSeptember 8, 1995
K936251light diagnosticsCOXSACKIEVIRUS B3 MONOCLONAL ANTIBODYSeptember 8, 1995
K940472chemicon intlCOXSACKIEVIRUS B5 MONOCLONAL ANTIBODYSeptember 8, 1995