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HYB — Eosin Y Class I

FDA Device Classification

Classification Details

Product Code
HYB
Device Class
Class I
Regulation Number
864.1850
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K893663shandonINSTANT EOSIN-AQUEOUSJune 13, 1989
K880596sigma chemicalEOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINEMarch 31, 1988
K880240shandonINSTANT EOSIN-ALCOHOLICMarch 3, 1988
K843426accra laboratoriesEOSIN Y 1% ALCOHOLICSeptember 27, 1984
K822982emd chemicalsMIDAS 100 HEMACOLOR STAIN #66030October 27, 1982
K821574sigma chemicalEOSIN Y SOLUTIN, AGUEOUSJune 10, 1982
K821573sigma chemicalEOSIN Y SOLUTION ALCHOLICJune 9, 1982
K811797richard-allan medical indEOSIN-YJuly 28, 1981
K811826surgipathEOSIN YJuly 10, 1981
K800942volu sol medical industriesVOLU-SOL EOSIN Y STAINMay 8, 1980