TRI-COUNT 16— 510(k) K902389

Substantially Equivalent

Hematronix, Inc.

FDA 510(k) clearance K902389 for TRI-COUNT 16, Substantially Equivalent on 1990-08-22. Applicant: Hematronix, Inc.. Device class: 2.

Clearance details

Applicant: Hematronix, Inc.
Product code: Code JCN
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1990-05-30
Decision date: 1990-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCN

K993825 — PARA TECH PLUS RETICS1999-11-30
K942209 — LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH1994-06-16
K934497 — CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE1993-12-06
K911582 — STAK-CHEX1991-05-28
K902391 — CELL-DYN 3000 CONTROL1990-08-22

More clearances from Hematronix, Inc.

K012243 — MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL2001-08-20
K993496 — RETIC-QUINOX1999-11-30
K972710 — QUANTIFY(901)1997-08-15
K960471 — TRI-COUNT 201996-03-20
K960005 — TRI-COURT 20-T1996-03-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.