JBQ · Class II · 21 CFR 864.7060

FDA Product Code JBQ: Antithrombin Iii Quantitation

Leading manufacturers include Instrumentation Laboratory CO, Pharmaseal Div., Baxter Healthcare Corp. and Ortho Diagnostics, 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 May 28, 2009
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
K081769
Siemens Healthcare Diagnostics
Hematology · 339d
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 Nov 07, 2005
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102
K043007
Hyphen Biomed
Hematology · 371d
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 26, 2000
K-ASSAY AT-III
K000361
Kamiya Biomedical Co.
Hematology · 82d
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 Jul 25, 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144
Sigma Diagnostics, Inc.
Hematology · 49d
Cleared Aug 14, 1996
SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
K960871
Medical Diagnostic Technologies, Inc.
Hematology · 163d
Cleared Jan 23, 1996
COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY
K952515
Chromogenix AB
Hematology · 237d
Cleared Nov 13, 1995
CHROM Z CHROMOGENIC ASSAYS
K951943
Helena Laboratories
Hematology · 201d
Cleared Apr 07, 1995
AT-III CALIBRATOR
K944279
American Bioproducts Co.
Hematology · 220d
Cleared Dec 22, 1994
BIOMERIEUX HEMOLAB AT III
K934156
Biomerieux Vitek, Inc.
Microbiology · 482d
Cleared May 17, 1994
ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY
K935308
Sigma Diagnostics, Inc.
Hematology · 196d
Cleared May 04, 1994
ANTITHROMBIN III CHROMOGENIC ASSAY
K936196
Baxter Diagnostics, Inc.
Hematology · 126d
Cleared Jan 03, 1992
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
K913667
The Binding Site, Ltd.
Hematology · 137d
Cleared Jan 24, 1991
LIATEST(R) AT III TEST KIT
K905110
American Bioproducts Co.
Hematology · 72d
Cleared Aug 06, 1990
BECKMAN ANTITHROMBIN III REAGENT KIT
K901977
Beckman Instruments, Inc.
Hematology · 96d
Cleared Mar 15, 1990
ORTHOKROME* ANTITHROMBIN
K900400
Ortho Diagnostic Systems, Inc.
Hematology · 45d

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 →