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510(k) K791651

Device
TOTAL ESTROGENS KIT BY RIA
Applicant
RADIOASSAY SYSTEMS LABORATORIES, INC.
510(k) number
K791651
Product code
JMD  
Decision
Substantially Equivalent (SESE)
Decision date
1979-09-27
Date received
1979-08-21
Regulation
862.1275
Classification name
Radioimmunoassay, Total Estrogens, Nonpregnancy
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 JMD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K781009ANALYZER, SERUM IRON & TOTAL IRON BINDINEnvironmental Sciences Assoc., Inc.1978-07-27

Legacy Summary#

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FDA Review#

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