Cleared Traditional

ASSERACHROM HPIA TEST KIT

K003767 · Diagnostica Stago, Inc. · Hematology
Feb 2001
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K003767 is an FDA 510(k) clearance for the ASSERACHROM HPIA TEST KIT, a Platelet Factor 4 Radioimmunoassay (Class II — Special Controls, product code LCO), submitted by Diagnostica Stago, Inc. (Parsippany, US). The FDA issued a Cleared decision on February 12, 2001, 68 days after receiving the submission on December 6, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7695.

Submission Details

510(k) Number K003767 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2000
Decision Date February 12, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code LCO — Platelet Factor 4 Radioimmunoassay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7695

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