Cleared Traditional

THE STACHROM HEPARIN ASSAY KIT

K925433 · American Bioproducts Co. · Hematology
May 1995
Decision
937d
Days
Class 2
Risk

About This 510(k) Submission

K925433 is an FDA 510(k) clearance for the THE STACHROM HEPARIN ASSAY KIT, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on May 23, 1995, 937 days after receiving the submission on October 28, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K925433 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1992
Decision Date May 23, 1995
Days to Decision 937 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KFF — Assay, Heparin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7525

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