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510(k) K882873

Device
FIELDTEX HEMATOXYLIN
Applicant
ANATECH, LTD.
510(k) number
K882873
Product code
KQC  
Decision
Substantially Equivalent (SESE)
Decision date
1988-07-28
Date received
1988-07-11
Regulation
864.1850
Classification name
Stains, Hematology
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FELDMAN, M.S.
Address
1020 Harts Lake Rd. Battle Creek MI US 49015 49015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K852843GENERAL DIAGNOSTICS COAG-A-MATE XCWarner-Lambert Co.1985-08-13
K843619RETIC-SETR&D Systems, Inc.1984-10-30
K841848RETIC-SETR&D Systems, Inc.1984-05-31
K792550PONCEAU S STAIN SETElectrophoresis Corp. of America1980-01-16
K792496VOLU-SOL NMB RETICULOCYTE STAINVolu Sol Medical Industries1979-12-31
K791007STAT DIFF STAINBioscientific1979-08-03
K760485HEMASTAIN FIXATIVEGeometric Data, Div. Smithkline Corp.1976-08-30
K760487HEMASTAIN PHOSPHATE BUFFERGeometric Data, Div. Smithkline Corp.1976-08-30

Legacy Summary#

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FDA Review#

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