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510(k) K844708

Device
TRI-COUNT CALIBRATOR
Applicant
HEMATOLOGY MARKETING ASSOC.
510(k) number
K844708
Product code
KSA  
Decision
Substantially Equivalent (SESE)
Decision date
1985-03-05
Date received
1984-12-03
Regulation
864.8185
Classification name
Calibrator For Red-cell And White-cell Counting
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES LAPICOLA
Address
P.O. Box 6756 Concord CA US 94524 94524

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943268SCS-1000 (SYSMEX CALIBRATOR SYSTEM)Streck Laboratories, Inc.1994-12-15
K897060CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLER&D Systems, Inc.1990-01-02
K881161TECH-CAL(TM)/MULTIPLER&D Systems, Inc.1988-05-02
K864664H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORSTechnicon Instruments Corp.1987-02-06
K854823CBC-CAL/MULTIPLER&D Systems, Inc.1986-02-13
K813530HEMOTOLOGY CALIBRATORAmerican Dade1982-02-22
K813375HEMATOLOGY CALIBRATOR S-CALCoulter Electronics, Inc.1982-02-04

Legacy Summary#

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FDA Review#

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