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510(k) K760197

Device
ACCUVETTE II
Applicant
COULTER ELECTRONICS, INC.
510(k) number
K760197
Product code
JRI  
Decision
Substantially Equivalent (SESE)
Decision date
1976-07-19
Date received
1976-07-06
Regulation
862.2050
Classification name
Cuvette, Thermostated
Medical specialty
Clinical Chemistry
Review panel
Immunology
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 JRI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K873656MEDATRON CUVETTE DISCMedatron, Inc.1987-12-14
K780888THERMO SET ELECTRONIC TEM. CONTROLLERGilford Instrument Laboratories, Inc.1978-06-28
K760769TEMPERATURE REGULATED FIVE CELL HOLDERSThe Perkin-Elmer Corp.1976-11-30

Legacy Summary#

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FDA Review#

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