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510(k) K820253

Device
SIMUL-FER SERUM IRON TEST KIT
Applicant
DIAGNOSTIC REAGENTS, INC.
510(k) number
K820253
Product code
JJA  
Decision
Substantially Equivalent (SESE)
Decision date
1982-05-12
Date received
1982-01-29
Regulation
862.1410
Classification name
Radio-labeled Iron Method, Iron (non-heme)
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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JJA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K782159DIAGNOSTIC KIT, FERRITAB-FE-59Leeco Diagnostics, Inc.1979-02-01
K781769IRON 59 KITRia Products, Inc.1978-12-04
K760045KIT, RADIOASSAY, SERUM IRONBd Becton Dickinson Vacutainer Systems Preanalytic1976-07-20

Legacy Summary#

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FDA Review#

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