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510(k) K840794

Device
S-CAL HEMATOLOGY CALIBRATOR
Applicant
COULTER ELECTRONICS, INC.
510(k) number
K840794
Product code
KRY  
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-04
Date received
1984-02-23
Regulation
864.8175
Classification name
Calibrator For Platelet Counting
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KRY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862122S-CAL HEMATOLOGY CALIBRATORCoulter Electronics, Inc.1987-05-20
K852016LASER PLATELETCAL/MULTIPLER&D Systems, Inc.1985-07-09
K843910COULTER MEAN PLATELET VOLUME CALIBRATORCoulter Electronics, Inc.1985-01-07
K821851CONTROL DIAGNOSTICS PLATELET CONTROLImmunogenetics1982-09-02
K781601TEKNI-CALStreck Laboratories, Inc.1978-10-10
K781133PC-CALIBRATORStreck Laboratories, Inc.1978-08-14
K770143TQC CALIBRATION REFERENCE FOR PLATELETSTechnicon Instruments Corp.1978-01-30

Legacy Summary#

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FDA Review#

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