COATEST(R) ANTITHROMBIN III, MODIFICATION— 510(k) K931420

Name: FDA 510(k) clearance K931420
Creator: U.S. Food and Drug Administration
Published: 1994-05-02

Substantially Equivalent

Kabi Pharmacia Hepar, Inc.

FDA 510(k) clearance K931420 for COATEST(R) ANTITHROMBIN III, MODIFICATION, Substantially Equivalent on 1994-05-02. Applicant: Kabi Pharmacia Hepar, Inc.. Device class: 2.

Clearance details

Applicant: Kabi Pharmacia Hepar, Inc.
Product code: Code JBQ
Device class: Class 2
Regulation: 21 CFR 864.7060
Advisory panel: Hematology
Date received: 1993-03-09
Decision date: 1994-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JBQ

view all

K242952 — INNOVANCE Antithrombin2025-03-28
K081769 — INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO52009-05-28
K070301 — HEMOSIL ANTITHROMBIN2007-02-23
K062431 — HEMOSIL LIQUID ANTITHROMBIN2006-09-01
K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 2211052005-11-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.