Cleared Traditional

AT-III CALIBRATOR

K944279 · American Bioproducts Co. · Hematology
Apr 1995
Decision
220d
Days
Class 2
Risk

About This 510(k) Submission

K944279 is an FDA 510(k) clearance for the AT-III CALIBRATOR, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by American Bioproducts Co. (Parisppany, US). The FDA issued a Cleared decision on April 7, 1995, 220 days after receiving the submission on August 30, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K944279 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 1994
Decision Date April 07, 1995
Days to Decision 220 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JBQ — Antithrombin Iii Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7060

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