|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
variant ii hemoglobin a1c program (new), variant ii hemoglobin testing system with cdm software, cdm software
|
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
|
K130860 |
04/25/2013
|
modification to variant ii: hemoglobin a1c program, beta-thalassemia short program and total ghb program
|
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
|
K063643 |
12/27/2006
|
d-10 hemoglobin a1c program; d-10 dual program
|
BIO-RAD LABORATORIES, INC.
|
K060001 |
01/20/2006
|
variant ii b-thalassemia
|
BIO-RAD
|
K991127 |
06/10/1999
|
variant beta-thalassemia short program
|
BIO-RAD
|
K924122 |
03/11/1993
|
hemoglobin a2 micro column test
|
BIO-RAD
|
K896168 |
01/18/1990
|
deter. of hemoglobin a2 using the diamat
|
BIO-RAD
|
K875102 |
02/24/1988
|