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510(k) K813530

HEMOTOLOGY CALIBRATOR by American Dade — Product Code KSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1982
Date Received
December 17, 1981
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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Other clearances for product code KSA

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  • K881161 — TECH-CAL(TM)/MULTIPLE (May 2, 1988)
  • K864664 — H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS (February 6, 1987)
  • K854823 — CBC-CAL/MULTIPLE (February 13, 1986)
  • K844708 — TRI-COUNT CALIBRATOR (March 5, 1985)
  • K813375 — HEMATOLOGY CALIBRATOR S-CAL (February 4, 1982)