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510(k) K864664

H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS by Technicon Instruments Corp. — Product Code KSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1987
Date Received
November 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Red-Cell And White-Cell Counting
Device Class
Class II
Regulation Number
864.8185
Review Panel
HE
Submission Type

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