JBQ — Antithrombin Iii Quantitation Class II
FDA product code JBQ covers "Antithrombin Iii Quantitation", a Class II medical device regulated under 21 CFR 864.7060. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JBQ
- Device Class
- Class II
- Regulation Number
- 864.7060
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242952 | siemens healthcare diagnostic products | INNOVANCE Antithrombin | March 28, 2025 |
| K081769 | siemens healthcare diagnostics | INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 | May 28, 2009 |
| K070301 | instrumentation laboratory | HEMOSIL ANTITHROMBIN | February 23, 2007 |
| K062431 | instrumentation laboratory | HEMOSIL LIQUID ANTITHROMBIN | September 1, 2006 |
| K043007 | hyphen biomed | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE | November 7, 2005 |
| K033775 | instrumentation laboratory | HEMOSIL LIQUID ANTITHROMBIN XL | January 2, 2004 |
| K023991 | precision biologic | CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 | April 28, 2003 |
| K022550 | instrumentation laboratory | COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS | August 27, 2002 |
| K022195 | instrumentation laboratory | COAMATIC AT-400 | August 7, 2002 |
| K994238 | instrumentation laboratory | IL TEST LIQUID ANTITHROMBIN | June 23, 2000 |
| K000361 | kamiya biomedical | K-ASSAY AT-III | April 26, 2000 |
| K980499 | instrumentation laboratory | IL TEST ANTITHROMBIN | April 2, 1998 |
| K974110 | beckman instruments | IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT | December 24, 1997 |
| K972144 | sigma diagnostics | SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III | July 25, 1997 |
| K960871 | medical diagnostic technologies | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) | August 14, 1996 |
| K952515 | chromogenix | COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY | January 23, 1996 |
| K951943 | helena laboratories | CHROM Z CHROMOGENIC ASSAYS | November 13, 1995 |
| K944279 | american bioproducts | AT-III CALIBRATOR | April 7, 1995 |
| K934156 | biomerieux vitek | BIOMERIEUX HEMOLAB AT III | December 22, 1994 |
| K935308 | sigma diagnostics | ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY | May 17, 1994 |