FDA.reportPublic FDA data

510(k) K820500

Device
TOTAL LIPID REAGENT SET
Applicant
ANCO MEDICAL REAGENTS & ASSOC.
510(k) number
K820500
Product code
CFD  
Decision
Substantially Equivalent (SESE)
Decision date
1982-03-11
Date received
1982-02-23
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#

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 CFD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863073TOTAL LIPIDSJ. D. Assoc.1986-09-09
K860112TOTAL LIPIDS REAGENT SETTechnostics Intl.1986-01-24
K813469LIPID PROFILEBio-Analytics Laboratories, Inc.1981-12-31

Legacy Summary#

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FDA Review#

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