HEMOCHRON JR. CITRATE APTT CUVETTE— 510(k) K014008

Substantially Equivalent

Itc, Inc.

FDA 510(k) clearance K014008 for HEMOCHRON JR. CITRATE APTT CUVETTE, Substantially Equivalent on 2002-01-24. Applicant: Itc, Inc.. Device class: 2.

Clearance details

Applicant: Itc, Inc.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2001-12-05
Decision date: 2002-01-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K014008

K-number listed on FDA's recall record

Z-0937-2014 — Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.Class II·Terminated·ITC-Nexus Dx·20131219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K014008.

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