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510(k) K902389

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

K902389 is an FDA 510(k) premarket notification submitted by Hematronix, Inc. for the device "TRI-COUNT 16". The FDA issued a decision of Substantially Equivalent on August 22, 1990. The device falls under product code JCN (Control, Cell Counter, Normal And Abnormal), a Class II device regulated under 21 CFR 864.8625. Hematronix, Inc. has at least 8 other 510(k) clearances on record.

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.

  • K012243 — MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL (August 20, 2001)
  • K993496 — RETIC-QUINOX (November 30, 1999)
  • 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)

FDA data resources