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510(k) K863073

Device
TOTAL LIPIDS
Applicant
J. D. ASSOC.
510(k) number
K863073
Product code
CFD  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-09
Date received
1986-08-12
Regulation
862.1470
Classification name
Sulfophosphovanillin, Colorimetry, Total Lipids
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DI PIETRO
Address
163 Montclair Ave. Montclair NJ US 07042 07042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CFD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K860112TOTAL LIPIDS REAGENT SETTechnostics Intl.1986-01-24
K820500TOTAL LIPID REAGENT SETAnco Medical Reagents & Assoc.1982-03-11
K813469LIPID PROFILEBio-Analytics Laboratories, Inc.1981-12-31

Legacy Summary#

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FDA Review#

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