FDA Product Code
FDA Product Code JBQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7060
510(k) Clearances — 56 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K242952 | INNOVANCE Antithrombin | Siemens Healthcare Diagnostic Products GmbH | 2025-03-28 | Traditional | PDF ↗ |
| K081769 | INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 | Siemens Healthcare Diagnostics | 2009-05-28 | Traditional | PDF ↗ |
| K070301 | HEMOSIL ANTITHROMBIN | Instrumentation Laboratory CO | 2007-02-23 | Special | PDF ↗ |
| K062431 | HEMOSIL LIQUID ANTITHROMBIN | Instrumentation Laboratory CO | 2006-09-01 | Special | PDF ↗ |
| K043007 | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 | Hyphen Biomed | 2005-11-07 | Traditional | PDF ↗ |
| K033775 | HEMOSIL LIQUID ANTITHROMBIN XL | Instrumentation Laboratory CO | 2004-01-02 | Special | PDF ↗ |
| K023991 | CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 | Precision Biologic | 2003-04-28 | Traditional | PDF ↗ |
| K022550 | COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS | Instrumentation Laboratory CO | 2002-08-27 | Traditional | PDF ↗ |
| K022195 | COAMATIC AT-400 | Instrumentation Laboratory CO | 2002-08-07 | Traditional | PDF ↗ |
| K994238 | IL TEST LIQUID ANTITHROMBIN | Instrumentation Laboratory CO | 2000-06-23 | Traditional | PDF ↗ |
| K000361 | K-ASSAY AT-III | Kamiya Biomedical Co. | 2000-04-26 | Traditional | PDF ↗ |
| K980499 | IL TEST ANTITHROMBIN | Instrumentation Laboratory CO | 1998-04-02 | Traditional | PDF ↗ |
| K974110 | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | Beckman Instruments, Inc. | 1997-12-24 | Traditional | PDF ↗ |
| K972144 | SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III | Sigma Diagnostics, Inc. | 1997-07-25 | Traditional | PDF ↗ |
| K960871 | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | Medical Diagnostic Technologies, Inc. | 1996-08-14 | Traditional | PDF ↗ |
| K952515 | COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY | Chromogenix AB | 1996-01-23 | Traditional | PDF ↗ |
| K951943 | CHROM Z CHROMOGENIC ASSAYS | Helena Laboratories | 1995-11-13 | Traditional | PDF ↗ |
| K944279 | AT-III CALIBRATOR | American Bioproducts Co. | 1995-04-07 | Traditional | PDF ↗ |
| K934156 | BIOMERIEUX HEMOLAB AT III | Biomerieux Vitek, Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K935308 | ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY | Sigma Diagnostics, Inc. | 1994-05-17 | Traditional | PDF ↗ |
| K936196 | ANTITHROMBIN III CHROMOGENIC ASSAY | Baxter Diagnostics, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K931420 | COATEST(R) ANTITHROMBIN III, MODIFICATION | Kabi Pharmacia Hepar, Inc. | 1994-05-02 | Traditional | PDF ↗ |
| K913667 | ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT | The Binding Site, Ltd. | 1992-01-03 | Traditional | PDF ↗ |
| K915083 | COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY | Kabi Pharmacia, Inc. | 1992-01-03 | Traditional | PDF ↗ |
| K905110 | LIATEST(R) AT III TEST KIT | American Bioproducts Co. | 1991-01-24 | Traditional | PDF ↗ |
| K902393 | COACUTE ANTITHROMBIN CHROMOGENIC ASSAY | Kabi Diagnostica | 1990-09-25 | Traditional | PDF ↗ |
| K902530 | SPECTROLYSE ATIII KIT | Biopool AB | 1990-08-09 | Traditional | PDF ↗ |
| K901977 | BECKMAN ANTITHROMBIN III REAGENT KIT | Beckman Instruments, Inc. | 1990-08-06 | Traditional | PDF ↗ |
| K900400 | ORTHOKROME* ANTITHROMBIN | Ortho Diagnostic Systems, Inc. | 1990-03-15 | Traditional | PDF ↗ |
| K893608 | ACTICHROME ATIII KIT | American Diagnostic Corp. | 1989-06-23 | Traditional | PDF ↗ |
| K884144 | TURBOX ANTITHROMBIN III | Unipath , Ltd. | 1988-12-20 | Traditional | PDF ↗ |
| K883662 | BERICHROM(R) ANTITHROMBIN III | Behring Diagnostics, Inc. | 1988-11-23 | Traditional | PDF ↗ |
| K880700 | ENZYGNOST(R) TAT REAGENTS | Behring Diagnostics, Inc. | 1988-04-27 | Traditional | PDF ↗ |
| K880315 | DADE ANTITHROMBIN III CHROMOGENIC ASSAY | Baxter Healthcare Corp | 1988-03-16 | Traditional | PDF ↗ |
| K864214 | IL TEST 97574-15M, ANTITTHROMBIN III ASSASY | Instrumentation Laboratory CO | 1986-11-25 | Traditional | PDF ↗ |
| K850412 | GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY | Warner-Lambert Co. | 1985-05-08 | Traditional | PDF ↗ |
| K841736 | IL TEST ANTITHROMBIN III ACTIVITY | Instrumentation Laboratory CO | 1984-09-06 | Traditional | PDF ↗ |
| K832592 | DIACROM * ATIII | Wellcome Diagnostics | 1983-09-29 | Traditional | PDF ↗ |
| K832268 | RABBIT ANTI-HUMAN ANTITHROMBIN III | Gelco Diagnostics, Inc. | 1983-08-12 | Traditional | PDF ↗ |
| K831961 | IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN | Kent Laboratories, Inc. | 1983-08-11 | Traditional | PDF ↗ |
| K831297 | PROTOTRO/PROTEOLYTIC ENZYME CONTROL | American Dade | 1983-06-08 | Traditional | PDF ↗ |
| K812829 | COATEST ANTITHROMBIN | Kabivitrum, Inc. | 1981-12-30 | Traditional | PDF ↗ |
| K812626 | ACA ANTITHROMBIN III PLASMINOGEN CALIB | E.I. Dupont DE Nemours & Co., Inc. | 1981-11-24 | Traditional | PDF ↗ |
| K812627 | ACA ANTITHROMBIN III TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1981-10-08 | Traditional | PDF ↗ |
| K812215 | ANTITHROMBIN III SCREEN KIT | Pacific Hemostasis | 1981-09-01 | Traditional | PDF ↗ |
| K802912 | HELENA AT-III QUIPLATE PROCEDURE | Helena Laboratories | 1980-12-22 | Traditional | PDF ↗ |
| K792019 | PHADECODE XA INHIBITOR ASSAY | Pharmaseal Div., Baxter Healthcare Corp. | 1979-11-05 | Traditional | PDF ↗ |
| K790090 | DETERMINATION OF ANTITHROMBIN III, 885 | Sigma Chemical Co. | 1979-02-26 | Traditional | PDF ↗ |
| K781860 | ASSAY, CHROMOGENIC ANTITHROMBIN III | Ortho Diagnostics, Inc. | 1978-12-04 | Traditional | PDF ↗ |
| K781480 | ANTITHROMBIN III ASSAY | Dade, Baxter Travenol Diagnostics, Inc. | 1978-11-08 | Traditional | PDF ↗ |
| K781026 | ANTITHROMBIN III SERUM, ANTI-HUMAN | Icl Scientific | 1978-08-10 | Traditional | PDF ↗ |
| K772328 | LAS-R HUMAN ANTITHROMBIN III TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-02-03 | Traditional | PDF ↗ |
| K780002 | ANTITHROMBIN III ASSAY | Ortho Diagnostics, Inc. | 1978-01-31 | Traditional | PDF ↗ |
| K771669 | DIAG. KIT FOR TOTAL ANTITHROMBIN III | Abbott Laboratories | 1977-11-09 | Traditional | PDF ↗ |
| K770942 | PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY | Pharmaseal Div., Baxter Healthcare Corp. | 1977-07-21 | Traditional | PDF ↗ |
| K770394 | THROMBO-SCREEN AT-111 KIT | Bay Area Hema. Onco. Clinic. & Res. L | 1977-03-30 | Traditional | PDF ↗ |
Product code JBQ · Class II · Hematology. Data: openFDA.