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510(k) K943268

Device
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
Applicant
STRECK LABORATORIES, INC.
510(k) number
K943268
Product code
KSA  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-15
Date received
1994-07-07
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
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
THEODORE W HEISE
Address
14306 Industrial Rd. P.O. Box 37625 Omaha NE US 68144 68144

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KSA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K844708TRI-COUNT CALIBRATORHematology Marketing Assoc.1985-03-05
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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