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510(k) K873656

Device
MEDATRON CUVETTE DISC
Applicant
MEDATRON, INC.
510(k) number
K873656
Product code
JRI  
Decision
Substantially Equivalent (SESE)
Decision date
1987-12-14
Date received
1987-09-10
Regulation
862.2050
Classification name
Cuvette, Thermostated
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KIM KAUFMANN
Address
C/O Professional Billing Co. 250 Bishops Way Brookfield WI US 53005 53005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JRI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K780888THERMO SET ELECTRONIC TEM. CONTROLLERGilford Instrument Laboratories, Inc.1978-06-28
K760769TEMPERATURE REGULATED FIVE CELL HOLDERSThe Perkin-Elmer Corp.1976-11-30
K760197ACCUVETTE IICoulter Electronics, Inc.1976-07-19

Legacy Summary#

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FDA Review#

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