Variant Hemoglobinopathy Program
FDA 510(k) K954048 · Bio-Rad
510(k) numberK954048
Submission
- Device name
- Variant Hemoglobinopathy Program
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- August 28, 1995
- Decision date
- November 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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Questions and answers
When was Variant Hemoglobinopathy Program cleared by the FDA?
Variant Hemoglobinopathy Program (K954048) received a 510(k) decision of Substantially Equivalent on November 20, 1995, 84 days after the submission was received.
What is the product code of K954048?
The FDA product code is GKA – Abnormal Hemoglobin Quantitation, a Class II (moderate risk) device regulated under 21 CFR 864.7415.