Product code JBQ
- Device name
- Antithrombin Iii Quantitation
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7060
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | 2025-03-28 |
| K081769 | INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 | Siemens Healthcare Diagnostics | 2009-05-28 |
| K070301 | HEMOSIL ANTITHROMBIN | Instrumentation Laboratory CO | 2007-02-23 |
| K062431 | HEMOSIL LIQUID ANTITHROMBIN | Instrumentation Laboratory CO | 2006-09-01 |
| K043007 | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 | Hyphen Biomed | 2005-11-07 |
| K033775 | HEMOSIL LIQUID ANTITHROMBIN XL | Instrumentation Laboratory CO | 2004-01-02 |
| K023991 | CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 | Precision Biologic | 2003-04-28 |
| K022550 | COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS | Instrumentation Laboratory CO | 2002-08-27 |
| K022195 | COAMATIC AT-400 | Instrumentation Laboratory CO | 2002-08-07 |
| K994238 | IL TEST LIQUID ANTITHROMBIN | Instrumentation Laboratory CO | 2000-06-23 |
| K000361 | K-ASSAY AT-III | Kamiya Biomedical Co. | 2000-04-26 |
| K980499 | IL TEST ANTITHROMBIN | Instrumentation Laboratory CO | 1998-04-02 |
| K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | Beckman Instruments, Inc. | 1997-12-24 |
| K972144 | SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III | Sigma Diagnostics, Inc. | 1997-07-25 |
| K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | Medical Diagnostic Technologies, Inc. | 1996-08-14 |
| K952515 | COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY | Chromogenix AB | 1996-01-23 |
| K951943 | CHROM Z CHROMOGENIC ASSAYS | Helena Laboratories | 1995-11-13 |
| K944279 | AT-III CALIBRATOR | American Bioproducts Co. | 1995-04-07 |
| K934156 | BIOMERIEUX HEMOLAB AT III | Biomerieux Vitek, Inc. | 1994-12-22 |
| K935308 | ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY | Sigma Diagnostics, Inc. | 1994-05-17 |
| K936196 | ANTITHROMBIN III CHROMOGENIC ASSAY | Baxter Diagnostics, Inc. | 1994-05-04 |
| K931420 | COATEST(R) ANTITHROMBIN III, MODIFICATION | Kabi Pharmacia Hepar, Inc. | 1994-05-02 |
| K915083 | COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY | Kabi Pharmacia, Inc. | 1992-01-03 |
| K913667 | ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1992-01-03 |
| K905110 | LIATEST(R) AT III TEST KIT | American Bioproducts Co. | 1991-01-24 |
| K902393 | COACUTE ANTITHROMBIN CHROMOGENIC ASSAY | Kabi Diagnostica | 1990-09-25 |
| K902530 | SPECTROLYSE ATIII KIT | Biopool AB | 1990-08-09 |
| K901977 | BECKMAN ANTITHROMBIN III REAGENT KIT | Beckman Instruments, Inc. | 1990-08-06 |
| K900400 | ORTHOKROME* ANTITHROMBIN | Ortho Diagnostic Systems, Inc. | 1990-03-15 |
| K893608 | ACTICHROME ATIII KIT | American Diagnostic Corp. | 1989-06-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414639673 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639680 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639796 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00195226000061 | HemosIL Liquid Antithrombin | INSTRUMENTATION LABORATORY COMPANY | 2021-01-29 |
| 00842768037146 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostics Products GmbH | 2020-05-07 |
| 00842768013065 | Enzygnost® TAT micro | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 05051700010702 | Human Antithrombin III BINDARID™ Radial Immunodiffusion Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| B1761485 | Antithrombin III RID plate package | KENT LABORATORIES INC | 2016-09-24 |
| B1761484 | Antithrombin III RID plate package | KENT LABORATORIES INC | 2016-09-24 |
| B1761480 | Antiserum to Human Antithrombin III | KENT LABORATORIES INC | 2016-09-24 |
| 00842768027017 | INNOVANCE® Antithrombin | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768027024 | INNOVANCE® Antithrombin | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 08426950062325 | HemosIL Antithrombin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950440802 | HemosIL Liquid Antithrombin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950088936 | Coamatic LR Antithrombin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950088868 | Coamatic Antithrombin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950087571 | HemosIL Liquid AT Substrate | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950056003 | HemosIL Liquid Antithrombin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950358701 | HemosIL Liquid Antithrombin | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 00850201006086 | ACTICHROME ATIII KIT | Biomedica ADI Inc. | 2016-09-20 |
| 03607450005967 | STA® - Stachrom® AT III 3 | DIAGNOSTICA STAGO | 2016-09-15 |
| 03607450005684 | Liatest® AT III | DIAGNOSTICA STAGO | 2016-09-15 |
| 05391521420534 | TriniCHROM™ Antithrombin IIa | TCOAG IRELAND LIMITED | 2016-09-12 |
| 05391521420541 | TriniCHROM™ Antithrombin Xa | TCOAG IRELAND LIMITED | 2016-09-12 |
| 03663537008214 | BIOPHEN Antithrombin 5 | HYPHEN BIOMED | 2016-08-25 |
| 03663537008207 | BIOPHEN Antithrombin 2.5 | HYPHEN BIOMED | 2016-08-25 |