510(k) K872912

Device
TRIGLYCERIDE (UV) REAGENT
Applicant
SIGMA CHEMICAL CO.
510(k) number
K872912
Product code
JGW  
Decision
Substantially Equivalent (SESE)
Decision date
1987-08-17
Date received
1987-07-24
Regulation
862.1705
Classification name
Fluorometric Method, Triglycerides
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MATHEW MADAPPALLY
Address
P.O. Box 14508 St. Louis MO US 63178 63178

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JGW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K852556TDX REA TRIGLYCERIDESAbbott Laboratories1985-07-22
K780439PRECIMAT GLYCEROLBoehringer Mannheim Corp.1978-04-18

Legacy Summary#

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FDA Review#

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