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510(k) K891907

QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED by R&D Systems, Inc. — Product Code JCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1989
Date Received
March 27, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Cell Counter, Normal And Abnormal
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

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  • K070334 — R&D SICKLE QC CONTROL (March 29, 2007)

Other clearances for product code JCN

  • K993825 — PARA TECH PLUS RETICS (November 30, 1999)
  • K942209 — LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH (June 16, 1994)
  • K934497 — CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE (December 6, 1993)
  • K911582 — STAK-CHEX (May 28, 1991)
  • K902389 — TRI-COUNT 16 (August 22, 1990)
  • K902391 — CELL-DYN 3000 CONTROL (August 22, 1990)
  • K901875 — PARA 12 PLUS (May 30, 1990)
  • K896154 — PARA TECH FOR TECHNICON H-1 (November 9, 1989)
  • K895373 — HEMATOLOGY CONTROL (October 6, 1989)
  • K874386 — CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE (December 30, 1987)