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510(k) K905829

Device
DETERMINER PL/DETERMINATION OF PHOSPHOLIPIDS
Applicant
KAMIYA BIOMEDICAL CO.
510(k) number
K905829
Product code
CEL  
Decision
Substantially Equivalent (SESE)
Decision date
1991-01-30
Date received
1990-12-31
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#

Contact
MARY REES
Address
P.O. Box 6067 Thousand Oaks CA US 91359 91359

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
K884169DU PONT ANALYST THYROID ROTORThe DU Pont Co.1989-01-24
K801076WAKO PHOSPHOLIPIDS TESTWako Pure Chemical Industries, Ltd.1980-06-30

Legacy Summary#

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FDA Review#

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