Bio-Rad Laboratories Inc., Clinical Systems Divisi is one of 23826 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bio-Rad Laboratories Inc., Clinical Systems Divisi - FDA 510(k) Clear...
Recent clearances: VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH, VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK HEMOGLOBIN TESTING WITH MODEL, 270-2716,, MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM
3
Total
3
Cleared
0
Denied
Bio-Rad Laboratories Inc., Clinical Systems Divisi has 3 FDA 510(k) cleared medical devices. Based in Hercules, US.
Historical record: 3 cleared submissions from 2006 to 2008. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Bio-Rad Laboratories Inc., Clinical Systems Divisi Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Bio-Rad Laboratories Inc., Clinical Systems Divisi
3 devices
Cleared
May 02, 2008
VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING...
Hematology
30d
Cleared
Jun 25, 2007
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM, AND VARIANT II TURBO LINK...
Chemistry
91d
Cleared
Dec 27, 2006
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT...
Chemistry
20d