FDA 510(k) Applications Submitted by KAREN ANDERSON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100307 |
02/03/2010 |
GELSCAN, MODEL 1206 |
SEBIA |
| K070486 |
02/20/2007 |
CAPILLARYS URINE (PN 2012) |
Sebia, Inc. |
| K130500 |
02/26/2013 |
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT |
SEBIA |
| K210623 |
03/02/2021 |
FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 |
Sebia |
| K180762 |
03/23/2018 |
CAPI 3 HEMOGLOBIN(E) |
SEBIA |
| K080916 |
04/02/2008 |
CAPILLARYS URINE |
SEBIA |
| K190851 |
04/02/2019 |
HYDRASHIFT 2/4 daratumumab |
Sebia |
| K091283 |
05/01/2009 |
CAPILLARYS NEONAT HB (PN 2006) |
SEBIA |
| K171861 |
06/22/2017 |
CAPILLARYS Hb A1c |
Sebia |
| K101863 |
07/02/2010 |
IT/IF CONTROL |
SEBIA |
| K161928 |
07/14/2016 |
CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL |
Sebia |
| K122101 |
07/16/2012 |
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C |
SEBIA |
| K172195 |
07/21/2017 |
HYDRASHIFT 2/4 daratumumab, daratumumab Control |
Sebia |
| K082085 |
07/23/2008 |
CAPILLARYS IMMUNOTYPING, MODEL 2100 |
SEBIA |
| K192095 |
08/05/2019 |
CAPI 3 Immunotyping, Capillarys 3 Tera |
Sebia |
| K082227 |
08/07/2008 |
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 |
SEBIA |
| K162281 |
08/15/2016 |
CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) |
SEBIA |
| K082388 |
08/19/2008 |
MINICAP IMMUNOTYPING, MODEL: 2300 |
SEBIA |
| K052291 |
08/23/2005 |
CAPILLARY'S HEMOGLOBIN(E) (PN 2007) |
SEBIA |
| K112491 |
08/29/2011 |
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 |
SEBIA |
| K112550 |
09/01/2011 |
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM |
SEBIA |
| K203184 |
10/27/2020 |
HYDRASHIFT 2/4 isatuximab |
Sebia |
| K133344 |
10/30/2013 |
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS |
SEBIA |
| K063498 |
11/20/2006 |
HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356) |
SEBIA |
| K143483 |
12/08/2014 |
MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING |
SEBIA |
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