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GOE — Antisera, Fluorescent, Poliovirus 1-3 Class I

FDA Device Classification

Classification Details

Product Code
GOE
Device Class
Class I
Regulation Number
866.3405
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K940027chemicon intlENTEROVIRUS BLEND MONOCLONAL ANTIBODIESSeptember 12, 1995
K940017light diagnosticsPOLIOVIRUS 3 MONOCLONAL ANTIBODYSeptember 12, 1995
K940026light diagnosticsPOLIOVIRUS BLEND MONOCLONAL ANTIBODIESSeptember 12, 1995
K940034light diagnosticsPOLIOVIRUS 2 MONOCLONAL ANTIBODYSeptember 12, 1995
K940473chemicon intlENTEROVIRUS 71 MONOCLONAL ANTIBODYSeptember 12, 1995
K940363light diagnosticsENTEROVIRUS 70 MONCLONAL ANTIBODYSeptember 8, 1995
K940018light diagnosticsPOLIOVIRUS 1 MONOCLONAL ANTIBODYSeptember 8, 1995