Variant Sickle Cell Short Program
FDA 510(k) K924813 · Bio-Rad
510(k) numberK924813
Submission
- Device name
- Variant Sickle Cell Short Program
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- September 25, 1992
- Decision date
- January 14, 1993
- 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
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| 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 |
| K082227 | Minicap Hemoglobin(E) Kit, Model 2207, 2227GKA · Traditional | Sebia | 03/26/2009SE |
| 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 |
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Questions and answers
When was Variant Sickle Cell Short Program cleared by the FDA?
Variant Sickle Cell Short Program (K924813) received a 510(k) decision of Substantially Equivalent on January 14, 1993, 111 days after the submission was received.
What is the product code of K924813?
The FDA product code is GKA – Abnormal Hemoglobin Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7415.