Cleared Traditional

ANTITHROMBIN III CHROMOGENIC ASSAY

K936196 · Baxter Diagnostics, Inc. · Hematology
May 1994
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K936196 is an FDA 510(k) clearance for the ANTITHROMBIN III CHROMOGENIC ASSAY, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Baxter Diagnostics, Inc. (Miami, US). The FDA issued a Cleared decision on May 4, 1994, 126 days after receiving the submission on December 29, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K936196 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1993
Decision Date May 04, 1994
Days to Decision 126 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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