GKA — Abnormal Hemoglobin Quantitation Class II
FDA product code GKA covers "Abnormal Hemoglobin Quantitation", a Class II medical device regulated under 21 CFR 864.7415. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKA
- Device Class
- Class II
- Regulation Number
- 864.7415
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232027 | sebia | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument | April 4, 2024 |
| K222635 | trinity biotech (primus corporation, dba trinity biotech) | Premier Resolution System | August 4, 2023 |
| K192931 | helena laboratories | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | April 19, 2022 |
| K180762 | sebia | CAPI 3 HEMOGLOBIN(E) | December 14, 2018 |
| K171664 | bio-rad laboratories | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview So | September 13, 2017 |
| K112550 | sebia | CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM | May 25, 2012 |
| K112491 | sebia | SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 | May 24, 2012 |
| K091283 | sebia | CAPILLARYS NEONAT HB (PN 2006) | February 22, 2010 |
| K082227 | sebia | MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 | March 26, 2009 |
| K080911 | bio-rad laboratories inc., clinical systems divisi | VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTE | May 2, 2008 |
| K052291 | sebia | CAPILLARY'S HEMOGLOBIN(E) (PN 2007) | June 27, 2006 |
| K050709 | wallac | RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, | March 8, 2006 |
| K051072 | bio-rad laboratories | BIO-RAD VARIANT NBS SICKLE CELL PROGRAM | May 12, 2005 |
| K040146 | interlab | INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM | May 4, 2004 |
| K955355 | bio-rad | VARIANT ALPHA-THALASSEMIA SHORT PROGRAM | April 26, 1996 |
| K955283 | primus | PRIMUS VARIANT SYSTEM PVS99 | March 1, 1996 |
| K954048 | bio-rad | VARIANT HEMOGLOBINOPATHY PROGRAM | November 20, 1995 |
| K924813 | bio-rad | VARIANT SICKLE CELL SHORT PROGRAM | January 14, 1993 |
| K834595 | beckman instruments | PARAGON ACID HEMOGLOBIN REAGENT KIT | May 7, 1984 |
| K840011 | isolab | RESOLVE-HB | February 4, 1984 |