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FDA 510(k) Applications for Medical Device Product Code "JBQ"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K974110 | BECKMAN INSTRUMENTS, INC. | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | 12/24/1997 |
K952515 | CHROMOGENIX AB | COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY | 01/23/1996 |
K043007 | HYPHEN BIOMED | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 | 11/07/2005 |
K022195 | INSTRUMENTATION LABORATORY CO. | COAMATIC AT-400 | 08/07/2002 |
K022550 | INSTRUMENTATION LABORATORY CO. | COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS | 08/27/2002 |
K070301 | INSTRUMENTATION LABORATORY CO. | HEMOSIL ANTITHROMBIN | 02/23/2007 |
K062431 | INSTRUMENTATION LABORATORY CO. | HEMOSIL LIQUID ANTITHROMBIN | 09/01/2006 |
K033775 | INSTRUMENTATION LABORATORY CO. | HEMOSIL LIQUID ANTITHROMBIN XL | 01/02/2004 |
K980499 | INSTRUMENTATION LABORATORY CO. | IL TEST ANTITHROMBIN | 04/02/1998 |
K994238 | INSTRUMENTATION LABORATORY CO. | IL TEST LIQUID ANTITHROMBIN | 06/23/2000 |
K000361 | KAMIYA BIOMEDICAL CO. | K-ASSAY AT-III | 04/26/2000 |
K960871 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | 08/14/1996 |
K023991 | PRECISION BIOLOGIC | CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 | 04/28/2003 |
K081769 | SIEMENS HEALTHCARE DIAGNOSTICS | INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 | 05/28/2009 |
K972144 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III | 07/25/1997 |