JBQ · Class II · 21 CFR 864.7060

FDA Product Code JBQ: Antithrombin Iii Quantitation

Leading manufacturers include Instrumentation Laboratory CO, Helena Laboratories and E.I. Dupont DE Nemours & Co., Inc..

56
Total
56
Cleared
102d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 184d recently vs 100d historically

FDA 510(k) Cleared Antithrombin Iii Quantitation Devices (Product Code JBQ)

56 devices
1–24 of 56
Cleared Mar 28, 2025
INNOVANCE Antithrombin
K242952
Siemens Healthcare Diagnostic Products GmbH
Hematology · 184d
Cleared Feb 23, 2007
HEMOSIL ANTITHROMBIN
K070301
Instrumentation Laboratory CO
Hematology · 23d
Cleared Sep 01, 2006
HEMOSIL LIQUID ANTITHROMBIN
K062431
Instrumentation Laboratory CO
Hematology · 11d
Cleared Jan 02, 2004
HEMOSIL LIQUID ANTITHROMBIN XL
K033775
Instrumentation Laboratory CO
Hematology · 30d
Cleared Aug 27, 2002
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
K022550
Instrumentation Laboratory CO
Hematology · 25d
Cleared Aug 07, 2002
COAMATIC AT-400
K022195
Instrumentation Laboratory CO
Hematology · 33d
Cleared Jun 23, 2000
IL TEST LIQUID ANTITHROMBIN
K994238
Instrumentation Laboratory CO
Hematology · 190d
Cleared Apr 02, 1998
IL TEST ANTITHROMBIN
K980499
Instrumentation Laboratory CO
Hematology · 52d
Cleared Dec 24, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT
K974110
Beckman Instruments, Inc.
Hematology · 54d
Cleared Nov 13, 1995
CHROM Z CHROMOGENIC ASSAYS
K951943
Helena Laboratories
Hematology · 201d
Cleared Aug 06, 1990
BECKMAN ANTITHROMBIN III REAGENT KIT
K901977
Beckman Instruments, Inc.
Hematology · 96d
Cleared Mar 16, 1988
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
K880315
Baxter Healthcare Corp
Hematology · 50d
Cleared Nov 25, 1986
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214
Instrumentation Laboratory CO
Hematology · 28d
Cleared Sep 06, 1984
IL TEST ANTITHROMBIN III ACTIVITY
K841736
Instrumentation Laboratory CO
Hematology · 132d
Cleared Nov 24, 1981
ACA ANTITHROMBIN III PLASMINOGEN CALIB
K812626
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 70d
Cleared Oct 08, 1981
ACA ANTITHROMBIN III TEST PACK
K812627
E.I. Dupont DE Nemours & Co., Inc.
Hematology · 23d
Cleared Dec 22, 1980
HELENA AT-III QUIPLATE PROCEDURE
K802912
Helena Laboratories
Hematology · 34d
Cleared Feb 26, 1979
DETERMINATION OF ANTITHROMBIN III, 885
K790090
Sigma Chemical Co.
Hematology · 41d
Cleared Nov 09, 1977
DIAG. KIT FOR TOTAL ANTITHROMBIN III
K771669
Abbott Laboratories
Hematology · 69d

About Product Code JBQ - Regulatory Context

510(k) Submission Activity

56 total 510(k) submissions under product code JBQ since 1977, with 56 receiving FDA clearance (average review time: 102 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - JBQ Product Code

Recent submissions under JBQ have taken an average of 184 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.

JBQ devices are reviewed by the Hematology panel. Browse all Hematology devices →