| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | April 4, 2024 |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 | February 23, 2024 |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 | November 18, 2022 |
| K203184 | HYDRASHIFT 2/4 isatuximab | November 12, 2021 |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | November 1, 2019 |
| K190851 | HYDRASHIFT 2/4 daratumumab | May 2, 2019 |
| K180762 | CAPI 3 HEMOGLOBIN(E) | December 14, 2018 |
| K171861 | CAPILLARYS Hb A1c | February 7, 2018 |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | January 11, 2018 |
| K171537 | CAPI 3 Hb A1c | September 12, 2017 |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | February 17, 2017 |
| K161928 | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | December 21, 2016 |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | January 8, 2015 |
| K133344 | MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS | March 28, 2014 |
| K130500 | CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUME | July 26, 2013 |
| K122101 | CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C | December 6, 2012 |
| K112550 | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM | May 25, 2012 |
| K112491 | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 | May 24, 2012 |
| K101863 | IT/IF CONTROL | November 7, 2011 |
| K100307 | GELSCAN, MODEL 1206 | August 31, 2010 |