HZJ — Stain, Papanicolau Class I

FDA Device Classification

Classification Details

Product Code
HZJ
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
K843427accra laboratoriesGILL PAPANICOLAOU STAIN EA-1 & 2 OG-6October 2, 1984
K842739e k indPAP STAIN, EA-36September 11, 1984
K842735e k indPAP STAIN EA-65September 11, 1984
K842736e k indPAP STAIN, OG-6August 17, 1984
K842738e k indPAP STAIN EA-50August 17, 1984
K840054sigma chemicalPAPANICOLAOU STAIN SYS HT40February 17, 1984
K822035volu sol medical industriesVOLU-SOL GILLS EAAugust 3, 1982
K820027surgipathMODIFIED EA 50February 4, 1982
K812087surgipathEA 50August 13, 1981
K812086surgipathEA 65August 13, 1981
K800325volu sol medical industriesVOLU-SOL HISTO./CYTO. STAIN MOD. #EA65February 26, 1980
K800322volu sol medical industriesVOLU-SOL EA-50 STAINFebruary 26, 1980
K781583bioscientificPAPANICOLAOU STAIN :EA-50:October 10, 1978
K781582bioscientificPAPANICOLAOU STAIN EA-36October 10, 1978
K781588bioscientificPAPANICOLAOU STIAN OG-6October 10, 1978