Panels › Hematology › Product code GKA · Class 2
Abnormal Hemoglobin Quantitation
Regulation 864.7415
0510(k)s in 12 months (23 all time)
0recalls in 12 months (10 all time)
4recalls that name a 510(k)
Top companies in GKA
| Company | 510(k)s | Recalls |
|---|---|---|
| Sebia | 7 | 0 |
| Bio-Rad Laboratories, Inc. | 2 | 3 |
| Clark Laboratories, Inc. (dba,Trinity Biotech USA) | 0 | 5 |
| Bio-Rad | 3 | 0 |
| Helena Laboratories | 3 | 0 |
| Primus Corp. | 1 | 1 |
| Beckman Instruments, Inc. | 1 | 0 |
| Bio-Rad Laboratories Inc., Clinical Systems Divisi | 1 | 0 |
| Interlab S.R.L. | 1 | 0 |
| Isolab, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 4, 2024 | K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument Sebia | GKA |
| Aug 4, 2023 | K222635 | Premier Resolution System Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | GKA |
| Apr 19, 2022 | K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control Helena Laboratories, Corp. | GKA |
| Dec 14, 2018 | K180762 | CAPI 3 HEMOGLOBIN(E) Sebia | GKA |
| Sep 13, 2017 | K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software Bio-Rad Laboratories, Inc. | GKA |
| May 25, 2012 | K112550 | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM Sebia | GKA |
| May 24, 2012 | K112491 | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 Sebia, FR | GKA |
| Feb 22, 2010 | K091283 | CAPILLARYS NEONAT HB (PN 2006) Sebia | GKA |
| Mar 26, 2009 | K082227 | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 Sebia | GKA |
| May 2, 2008 | K080911 | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH Bio-Rad Laboratories Inc., Clinical Systems Divisi | GKA |
| Jun 27, 2006 | K052291 | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) Sebia | GKA |
| Mar 8, 2006 | K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 Wallac OY, FI | GKA |
| May 12, 2005 | K051072 | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM Bio-Rad Laboratories, Inc. | GKA |
| May 4, 2004 | K040146 | INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM Interlab S.R.L. | GKA |
| Apr 26, 1996 | K955355 | VARIANT ALPHA-THALASSEMIA SHORT PROGRAM Bio-Rad | GKA |
| Mar 1, 1996 | K955283 | PRIMUS VARIANT SYSTEM PVS99 Primus Corp. | GKA |
| Nov 20, 1995 | K954048 | VARIANT HEMOGLOBINOPATHY PROGRAM Bio-Rad | GKA |
| Jan 14, 1993 | K924813 | VARIANT SICKLE CELL SHORT PROGRAM Bio-Rad | GKA |
| May 7, 1984 | K834595 | PARAGON ACID HEMOGLOBIN REAGENT KIT Beckman Instruments, Inc. | GKA |
| Feb 4, 1984 | K840011 | RESOLVE-HB Isolab, Inc. | GKA |
| Aug 5, 1982 | K822123 | ISOPROPANOL HEMOGLOBIN STABILITY TEST Helena Laboratories | GKA |
| Apr 1, 1982 | K820573 | HELENA HEMOGLOBIN DETECT COLUMN SYS Helena Laboratories | GKA |
| Jul 27, 1981 | K811894 | ORTHO SICKLE CELL CONTROLS Ortho Diagnostic Systems, Inc. | GKA |
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