METER TRAX— 510(k) K904461

Substantially Equivalent

Hematronix, Inc.

FDA 510(k) clearance K904461 for METER TRAX, Substantially Equivalent on 1990-10-26. Applicant: Hematronix, Inc.. Device class: 2.

Clearance details

Applicant: Hematronix, Inc.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1990-10-01
Decision date: 1990-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPK

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K160606 — BC-5D Hematology Control2016-09-01
K141957 — XN CHECK BF2014-12-05

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.