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510(k) K812081

Device
WAKO NEFA C TEST
Applicant
WAKO CHEMICALS, USA, INC.
510(k) number
K812081
Product code
JLG  
Decision
Substantially Equivalent (SESE)
Decision date
1981-08-12
Date received
1981-07-22
Regulation
862.1290
Classification name
Conversion To Ferric Hydroxymates (colorimetric), Fatty Acids
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JLG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K760750STERILE TUBULAR UNBLEACHED STOCKINETTEDennison Manufacturing Co.1976-10-08

Legacy Summary#

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FDA Review#

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