|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
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d-100 hba1c, d-100 hba1c calibrator pack
|
Bio-Rad Laboratories, Inc.
|
K151321 |
12/09/2015
|
variant ii turbo link hemoglobin a1c program/testing system
|
BIO-RAD LABORATORIES, INC.
|
K140801 |
06/25/2014
|
variant(tm) ii turbo hba1c kit - 2.0
|
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
|
K130990 |
05/09/2013
|
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
|
variant ii turbo hba1c kit-2.0 variant ii turbo hemoglobin testing system
|
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS
|
K122472 |
10/26/2012
|
variant ii turbo hba1c kit kit-20 and wash/diluent solution set, models 270-2455, 270-2730
|
BIO-RAD LABORATORIES, INC.
|
K090699 |
07/27/2009
|
hemoglobin capillary collection system (hccs), 1 test, hemoglobin capillary collection system (hccs), 5 tests, hemoglobi
|
BIO-RAD LABORATORIES, INC.
|
K090737 |
06/03/2009
|
variant ii turbo link hemoglobin a1c program, and variant ii turbo link hemoglobin testing with model, 270-2716,
|
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI
|
K070819 |
06/25/2007
|
variant ii hemoglobin a1c program with models 270-2101nu
|
BIO-RAD LABORATORIES, INC.
|
K070452 |
05/07/2007
|
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
|