FDA Product Code
FDA Product Code GKA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7415
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | Sebia | 2024-04-04 | Traditional | PDF ↗ |
| K222635 | Premier Resolution System | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | 2023-08-04 | Traditional | PDF ↗ |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | Helena Laboratories, Corp. | 2022-04-19 | Traditional | PDF ↗ |
| K180762 | CAPI 3 HEMOGLOBIN(E) | Sebia | 2018-12-14 | Traditional | PDF ↗ |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software | Bio-Rad Laboratories, Inc. | 2017-09-13 | Special | PDF ↗ |
| K112550 | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM | Sebia | 2012-05-25 | Traditional | PDF ↗ |
| K112491 | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 | Sebia | 2012-05-24 | Traditional | PDF ↗ |
| K091283 | CAPILLARYS NEONAT HB (PN 2006) | Sebia | 2010-02-22 | Traditional | PDF ↗ |
| K082227 | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 | Sebia | 2009-03-26 | Traditional | PDF ↗ |
| 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 | 2008-05-02 | Special | PDF ↗ |
| K052291 | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) | Sebia | 2006-06-27 | Traditional | PDF ↗ |
| K050709 | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367 | Wallac OY | 2006-03-08 | Traditional | PDF ↗ |
| K051072 | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM | Bio-Rad Laboratories, Inc. | 2005-05-12 | Traditional | PDF ↗ |
| K040146 | INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | Interlab S.R.L. | 2004-05-04 | Traditional | PDF ↗ |
| K955355 | VARIANT ALPHA-THALASSEMIA SHORT PROGRAM | Bio-Rad | 1996-04-26 | Traditional | PDF ↗ |
| K955283 | PRIMUS VARIANT SYSTEM PVS99 | Primus Corp. | 1996-03-01 | Traditional | PDF ↗ |
| K954048 | VARIANT HEMOGLOBINOPATHY PROGRAM | Bio-Rad | 1995-11-20 | Traditional | PDF ↗ |
| K924813 | VARIANT SICKLE CELL SHORT PROGRAM | Bio-Rad | 1993-01-14 | Traditional | PDF ↗ |
| K834595 | PARAGON ACID HEMOGLOBIN REAGENT KIT | Beckman Instruments, Inc. | 1984-05-07 | Traditional | PDF ↗ |
| K840011 | RESOLVE-HB | Isolab, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K822123 | ISOPROPANOL HEMOGLOBIN STABILITY TEST | Helena Laboratories | 1982-08-05 | Traditional | PDF ↗ |
| K820573 | HELENA HEMOGLOBIN DETECT COLUMN SYS | Helena Laboratories | 1982-04-01 | Traditional | PDF ↗ |
| K811894 | ORTHO SICKLE CELL CONTROLS | Ortho Diagnostic Systems, Inc. | 1981-07-27 | Traditional | PDF ↗ |
Product code GKA · Class II · Hematology. Data: openFDA.