| CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument (K232027) | Sebia | 2024-04-04 |
| Premier Resolution System (K222635) | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | 2023-08-04 |
| V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (K192931) | Helena Laboratories, Corp. | 2022-04-19 |
| CAPI 3 HEMOGLOBIN(E) (K180762) | Sebia | 2018-12-14 |
| Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software (K171664) | Bio-Rad Laboratories, Inc. | 2017-09-13 |
| CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM (K112550) | Sebia | 2012-05-25 |
| SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 (K112491) | Sebia | 2012-05-24 |
| CAPILLARYS NEONAT HB (PN 2006) (K091283) | Sebia | 2010-02-22 |
| MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 (K082227) | Sebia | 2009-03-26 |
| VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH (K080911) | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 2008-05-02 |
| CAPILLARY'S HEMOGLOBIN(E) (PN 2007) (K052291) | Sebia | 2006-06-27 |
| RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 (K050709) | Wallac OY | 2006-03-08 |
| BIO-RAD VARIANT NBS SICKLE CELL PROGRAM (K051072) | Bio-Rad Laboratories, Inc. | 2005-05-12 |
| INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (K040146) | Interlab S.R.L. | 2004-05-04 |
| VARIANT ALPHA-THALASSEMIA SHORT PROGRAM (K955355) | Bio-Rad | 1996-04-26 |
| PRIMUS VARIANT SYSTEM PVS99 (K955283) | Primus Corp. | 1996-03-01 |
| VARIANT HEMOGLOBINOPATHY PROGRAM (K954048) | Bio-Rad | 1995-11-20 |
| VARIANT SICKLE CELL SHORT PROGRAM (K924813) | Bio-Rad | 1993-01-14 |
| PARAGON ACID HEMOGLOBIN REAGENT KIT (K834595) | Beckman Instruments, Inc. | 1984-05-07 |
| RESOLVE-HB (K840011) | Isolab, Inc. | 1984-02-04 |
| ISOPROPANOL HEMOGLOBIN STABILITY TEST (K822123) | Helena Laboratories | 1982-08-05 |
| HELENA HEMOGLOBIN DETECT COLUMN SYS (K820573) | Helena Laboratories | 1982-04-01 |
| ORTHO SICKLE CELL CONTROLS (K811894) | Ortho Diagnostic Systems, Inc. | 1981-07-27 |