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510(k) K833677

Device
QUICK STAIN WRIGHT'S GIEMSA W/BUFF
Applicant
J.S. MEDICAL ASSOC.
510(k) number
K833677
Product code
HYF  
Decision
Substantially Equivalent (SESE)
Decision date
1983-11-25
Date received
1983-10-18
Regulation
864.1850
Classification name
Giemsa Stain
Medical specialty
Hematology
Review panel
Hematology
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 HYF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842742GIEMSA STAINE K Ind., Inc.1984-08-15
K833665HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACKJ.S. Medical Assoc.1983-11-25
K831131CASE WRIGHT-GIEMSA STAIN PAKCase Instruments1983-06-08

Legacy Summary#

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FDA Review#

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