Cleared Traditional

THROMBOLYTIC ACTIVITY TEST

K834301 · Bio/Data Corp. · Hematology
Feb 1984
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K834301 is an FDA 510(k) clearance for the THROMBOLYTIC ACTIVITY TEST, a Test, Thrombin Time (Class II — Special Controls, product code GJA), submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 57 days after receiving the submission on December 9, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7875.

Submission Details

510(k) Number K834301 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1983
Decision Date February 04, 1984
Days to Decision 57 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GJA — Test, Thrombin Time
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7875

Similar Devices — GJA Test, Thrombin Time

All 19
T-TEK
K050817 · R2 Diagnostics, Inc. · Dec 2005
ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589
K982209 · Sigma Diagnostics, Inc. · Oct 1998
BC THROMBIN REAGENT
K970645 · Behring Diagnostics, Inc. · May 1997
BIOMERIEUX HEMOLAB THROMBICALCI-TEST
K925493 · Biomerieux Vitek, Inc. · Apr 1994
TEST THROMBIN
K930157 · Behring Diagnostics, Inc. · May 1993
THROMBIN CLOT TIME TEST PROCEDURE
K923220 · Medical Laboratory Automation Systems, Inc. · Sep 1992