Cleared Traditional

RABBIT ANTI-HUMAN ANTITHROMBIN III

K832268 · Gelco Diagnostics, Inc. · Hematology
Aug 1983
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K832268 is an FDA 510(k) clearance for the RABBIT ANTI-HUMAN ANTITHROMBIN III, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Gelco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 43 days after receiving the submission on June 30, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K832268 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1983
Decision Date August 12, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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

Similar Devices — JBQ Antithrombin Iii Quantitation

All 55
INNOVANCE Antithrombin
K242952 · Siemens Healthcare Diagnostic Products GmbH · Mar 2025
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769 · Siemens Healthcare Diagnostics · May 2009
HEMOSIL ANTITHROMBIN
K070301 · Instrumentation Laboratory CO · Feb 2007
HEMOSIL LIQUID ANTITHROMBIN
K062431 · Instrumentation Laboratory CO · Sep 2006
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105
K043007 · Hyphen Biomed · Nov 2005
HEMOSIL LIQUID ANTITHROMBIN XL
K033775 · Instrumentation Laboratory CO · Jan 2004