ASSERACHROM HPIA TEST KIT— 510(k) K003767

Name: FDA 510(k) clearance K003767
Creator: U.S. Food and Drug Administration
Published: 2001-02-12

Substantially Equivalent

Diagnostica Stago, Inc.

FDA 510(k) clearance K003767 for ASSERACHROM HPIA TEST KIT, Substantially Equivalent on 2001-02-12. Applicant: Diagnostica Stago, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostica Stago, Inc.
Product code: Code LCO
Device class: Class 2
Regulation: 21 CFR 864.7695
Advisory panel: Hematology
Date received: 2000-12-06
Decision date: 2001-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K003767

K-number listed on FDA's recall record

Z-1084-2026 — Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.Class II·Ongoing·Diagnostica Stago, Inc.·20251215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003767.

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