Cleared Traditional

HEPARIN CONTROL KIT

K943520 · American Bioproducts Co. · Hematology
Sep 1995
Decision
432d
Days
Class 2
Risk

About This 510(k) Submission

K943520 is an FDA 510(k) clearance for the HEPARIN CONTROL KIT, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on September 26, 1995, 432 days after receiving the submission on July 21, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K943520 FDA.gov
FDA Decision Cleared SESK
Date Received July 21, 1994
Decision Date September 26, 1995
Days to Decision 432 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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