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510(k) K801076

Device
WAKO PHOSPHOLIPIDS TEST
Applicant
WAKO PURE CHEMICAL INDUSTRIES, LTD.
510(k) number
K801076
Product code
CEL  
Decision
Substantially Equivalent (SESE)
Decision date
1980-06-30
Date received
1980-05-07
Regulation
862.1575
Classification name
Ammonium Molybdate And Ammonium Vanadate, Phospholipids
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
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 CEL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K905829DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDSKamiya Biomedical Co.1991-01-30
K884169DU PONT ANALYST THYROID ROTORThe DU Pont Co.1989-01-24

Legacy Summary#

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FDA Review#

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