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510(k) K934497

CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE by R&D Systems, Inc. — Product Code JCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1993
Date Received
September 14, 1993
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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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)
  • K911582 — STAK-CHEX (May 28, 1991)
  • K902391 — CELL-DYN 3000 CONTROL (August 22, 1990)
  • K902389 — TRI-COUNT 16 (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)
  • K891907 — QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED (April 11, 1989)
  • K874386 — CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE (December 30, 1987)