FDA 510(k) Applications Submitted by JACKIE BUCKLEY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K060001 |
01/03/2006 |
D-10 HEMOGLOBIN A1C PROGRAM; D-10 DUAL PROGRAM |
BIO-RAD LABORATORIES, INC. |
| K031043 |
04/01/2003 |
D-10 HEMOGLOBIN A1C |
BIO-RAD LABORATORIES, INC. |
| K040872 |
04/02/2004 |
VARIANT II HEMOGLOBIN A1C |
BIO-RAD LABORATORIES, INC. |
| K151321 |
05/18/2015 |
D-100 HbA1c, D-100 HbA1c Calibrator Pack |
Bio-Rad Laboratories, Inc. |
| K041444 |
06/01/2004 |
BIO-RAD D-10 DUAL PROGRAM |
BIO-RAD LABORATORIES, INC. |
| K161687 |
06/17/2016 |
D-10 Hemoglobin A1c Program |
BIO-RAD LABORATORIES, INC. |
| K122472 |
08/14/2012 |
VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM |
BIO-RAD LABORATORIES, INC., CLINICAL SYSTEMS DIVIS |
| K142448 |
09/02/2014 |
VARIANT II TURBO HbA1c Kit - 2.0 |
Bio-Rad Laboratories, Inc. |
| K003280 |
10/19/2000 |
VARIANT II TOTAL GHB |
BIO-RAD |
| K063400 |
11/09/2006 |
VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 |
BIO-RAD LABORATORIES, INC. |
| K063643 |
12/07/2006 |
MODIFICATION TO VARIANT II: HEMOGLOBIN A1C PROGRAM, BETA-THALASSEMIA SHORT PROGRAM AND TOTAL GHB PROGRAM |
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
| K070452 |
02/16/2007 |
VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU |
BIO-RAD LABORATORIES, INC. |
| K090699 |
03/17/2009 |
VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 |
BIO-RAD LABORATORIES, INC. |
| K070819 |
03/26/2007 |
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 |
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