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510(k) K902389

TRI-COUNT 16 by Hematronix, Inc. — Product Code JCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1990
Date Received
May 30, 1990
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

Other clearances by Hematronix, Inc.

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  • K972710 — QUANTIFY(901) (August 15, 1997)
  • K960471 — TRI-COUNT 20 (March 20, 1996)
  • K960005 — TRI-COURT 20-T (March 19, 1996)
  • K941965 — EZ-RANGE (April 25, 1995)
  • K935343 — CENTRIFIQ BLOOD CONTROL (January 27, 1994)
  • K904461 — METER TRAX (October 26, 1990)

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)
  • 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)
  • K891907 — QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED (April 11, 1989)
  • K874386 — CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE (December 30, 1987)