TRI-COUNT 20— 510(k) K960471

Substantially Equivalent

Hematronix, Inc.

FDA 510(k) clearance K960471 for TRI-COUNT 20, Substantially Equivalent on 1996-03-20. 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: 1996-02-01
Decision date: 1996-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benicia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPK

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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
K960005 — TRI-COURT 20-T1996-03-19
K941965 — EZ-RANGE1995-04-25

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