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510(k) K781583

Device
PAPANICOLAOU STAIN :EA-50:
Applicant
BIOSCIENTIFIC
510(k) number
K781583
Product code
HZJ  
Decision
Substantially Equivalent (SESE)
Decision date
1978-10-10
Date received
1978-09-18
Regulation
864.1850
Classification name
Stain, Papanicolau
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HZJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843427GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6Accra Laboratories, Inc.1984-10-02
K842735PAP STAIN EA-65E K Ind., Inc.1984-09-11
K842739PAP STAIN, EA-36E K Ind., Inc.1984-09-11
K842736PAP STAIN, OG-6E K Ind., Inc.1984-08-17
K842738PAP STAIN EA-50E K Ind., Inc.1984-08-17
K840054PAPANICOLAOU STAIN SYS HT40Sigma Chemical Co.1984-02-17
K822035VOLU-SOL GILLS EAVolu Sol Medical Industries1982-08-03
K820027MODIFIED EA 50Surgipath1982-02-04
K812086EA 65Surgipath1981-08-13
K812087EA 50Surgipath1981-08-13
K800322VOLU-SOL EA-50 STAINVolu Sol Medical Industries1980-02-26
K800325VOLU-SOL HISTO./CYTO. STAIN MOD. #EA65Volu Sol Medical Industries1980-02-26
K781582PAPANICOLAOU STAIN EA-36Bioscientific1978-10-10
K781588PAPANICOLAOU STIAN OG-6Bioscientific1978-10-10

Legacy Summary#

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FDA Review#

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