Minicap Hemoglobin(E) Kit, Model 2207, 2227
FDA 510(k) K082227 · Sebia
510(k) numberK082227
Submission
- Device name
- Minicap Hemoglobin(E) Kit, Model 2207, 2227
- Applicant
- Sebia
Norcross, GA, US - Received
- August 7, 2008
- Decision date
- March 26, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GKA – Abnormal Hemoglobin Quantitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7415
- Specialty
- Hematology
Other 510(k)s with product code GKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | Sebia | 04/04/2024SE |
| K222635 | Premier Resolution SystemGKA · Traditional | Trinity Biotech (Primus Corporation, Dba Trinity… | 08/04/2023SE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional | Helena Laboratories, Corp. | 04/19/2022SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | Sebia | 12/14/2018SE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special | Bio-Rad Laboratories, Inc. | 09/13/2017SE |
| K112550 | Capillarys Hemoglobin, Capillarys Flex Piercing SystemGKA · Traditional | Sebia | 05/25/2012SE |
| K112491 | Sebia Capillarys Hemoglobin(E) with Capillarys 2GKA · Traditional | Sebia | 05/24/2012SE |
| K091283 | Capillarys Neonat HB (PN 2006)GKA · Traditional | Sebia | 02/22/2010SE |
| K080911 | Variant NBS Sickle Cell Program Reagent Kit, Variant NBS Newborn Screening System and…GKA · Special | Bio-Rad Laboratories Inc., Clinical Systems Divisi | 05/02/2008SE |
| K052291 | Capillary's Hemoglobin(E) (PN 2007)GKA · Traditional | Sebia | 06/27/2006SE |
More from Sebia
| 510(k) | Device | Decision |
|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | 04/04/2024SE |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | 02/23/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | 11/18/2022SE |
| K203184 | HYDRASHIFT 2/4 isatuximabCFF · Traditional | 11/12/2021SE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 TeraCFF · Traditional | 11/01/2019SE |
| K190851 | HYDRASHIFT 2/4 daratumumabCFF · Special | 05/02/2019SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | 12/14/2018SE |
| K171861 | CAPILLARYS Hb A1cPDJ · Traditional | 02/07/2018SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | 01/11/2018SE |
| K171537 | CAPI 3 Hb A1cPDJ · Traditional | 09/12/2017SE |
Questions and answers
When was Minicap Hemoglobin(E) Kit, Model 2207, 2227 cleared by the FDA?
Minicap Hemoglobin(E) Kit, Model 2207, 2227 (K082227) received a 510(k) decision of Substantially Equivalent on March 26, 2009, 231 days after the submission was received.
What is the product code of K082227?
The FDA product code is GKA – Abnormal Hemoglobin Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7415.