FDA.reportPublic FDA data

510(k) K860112

Device
TOTAL LIPIDS REAGENT SET
Applicant
TECHNOSTICS INTL.
510(k) number
K860112
Product code
CFD  
Decision
Substantially Equivalent (SESE)
Decision date
1986-01-24
Date received
1986-01-13
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
SUSAN RENEHAN
Address
P.O. Box 94090 Washington MI US 48094 48094

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
K820500TOTAL LIPID REAGENT SETAnco Medical Reagents & Assoc.1982-03-11
K813469LIPID PROFILEBio-Analytics Laboratories, Inc.1981-12-31

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases