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510(k) K854823

CBC-CAL/MULTIPLE by R&D Systems, Inc. — Product Code KSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1986
Date Received
December 3, 1985
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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  • K070334 — R&D SICKLE QC CONTROL (March 29, 2007)

Other clearances for product code KSA

  • K943268 — SCS-1000 (SYSMEX CALIBRATOR SYSTEM) (December 15, 1994)
  • K897060 — CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE (January 2, 1990)
  • K881161 — TECH-CAL(TM)/MULTIPLE (May 2, 1988)
  • K864664 — H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS (February 6, 1987)
  • K844708 — TRI-COUNT CALIBRATOR (March 5, 1985)
  • K813530 — HEMOTOLOGY CALIBRATOR (February 22, 1982)
  • K813375 — HEMATOLOGY CALIBRATOR S-CAL (February 4, 1982)