FDA.report

510(k) K833546

Device
MODIFICATION OF EMIT AND AMIKACIN ASSAY
Applicant
SYVA CO.
510(k) number
K833546
Product code
LDN  
Decision
Substantially Equivalent (SESE)
Decision date
1983-12-08
Date received
1983-10-14
Regulation
862.3035
Classification name
Enzymatic Radiochemical Assay, Amikacin
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Related Records

Applicant Contact

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LDN  

510(k)DeviceApplicantDecision date
K840647AMIKACIN REAGENT TEST KITBeckman Instruments, Inc.1984-04-02
K820440EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNOSyva Co.1982-03-15

Legacy Summary

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FDA Review

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