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510(k) K813366

Device
AMMONIA TEST
Applicant
WAKO PURE CHEMICAL INDUSTRIES, LTD.
510(k) number
K813366
Product code
JID  
Decision
Substantially Equivalent (SESE)
Decision date
1981-12-22
Date received
1981-11-30
Regulation
862.1065
Classification name
Photometric Method, Ammonia
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 JID  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991371CARESIDE AMMONIACareside, Inc.1999-08-03
K820723KODAK EKTACHEM CLINICAL CHEM. NH3Eastman Kodak Company1982-04-01

Legacy Summary#

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FDA Review#

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