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510(k) K840010

DADE HEMATOLOGY CALIBRATOR PLUS by American Dade — Product Code KRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1984
Date Received
January 4, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Hemoglobin And Hematocrit Measurement
Device Class
Class II
Regulation Number
864.8165
Review Panel
HE
Submission Type

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  • K902892 — CELL-DYN CALIBRATOR (September 10, 1990)
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  • K893984 — HGB-CAL SET/MULTIPLE (August 15, 1989)
  • K883851 — MSI-CAL 8 (November 22, 1988)
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  • K883703 — MSI-CAL 7 (November 22, 1988)