Hemoglobin S
Hemoglobin S (product code GIQ) is a hematology reagent or standard used to identify and characterize hemoglobin S, the abnormal hemoglobin variant responsible for sickle cell disease, through electrophoresis or other analytical techniques. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7415 in the Hematology specialty (HE), it is eligible for third-party review.
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Basic Information
- Product Code
- GIQ
- Device Class
- FDA class 2
- Regulation Number
- 864.7415
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K955719 | SICKLE-2000 | Aug 14, 1996 | Substantially Equivalent | Medicus Technologies, Inc. |
| K942276 | QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY | Jan 20, 1995 | Substantially Equivalent | Isolab, Inc. |
| K874429 | HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 | Feb 04, 1988 | Substantially Equivalent | Hf Scientific, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.