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510(k) K792416

Device
ELVI TOTAL PROTEINS
Applicant
VOLU SOL MEDICAL INDUSTRIES
510(k) number
K792416
Product code
CER  
Decision
Substantially Equivalent (SESE)
Decision date
1979-12-07
Date received
1979-11-26
Regulation
862.1440
Classification name
2,4-dinitrophenylhydrazine, Lactate Dehydrogenase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
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

Legacy Summary#

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FDA Review#

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