FDA product code GIQ: Hemoglobin S
GIQ is the FDA product code for hemoglobin s. It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under GIQ, from 3 different applicants. The average 510(k) review took 198 days (median 240).
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobin S |
| Device class | Class II |
| Regulation | 21 CFR 864.7415 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every GIQ clearance
Top GIQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medicus Technologies, Inc. | 1 | 1996-08-14 |
| Isolab, Inc. | 1 | 1995-01-20 |
| Hf Scientific, Inc. | 1 | 1988-02-04 |
Most recent GIQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955719 | Medicus Technologies, Inc. | SICKLE-2000 | 1996-08-14 | 240 |
| K942276 | Isolab, Inc. | QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY | 1995-01-20 | 255 |
| K874429 | Hf Scientific, Inc. | HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 | 1988-02-04 | 99 |
Recalls for GIQ devices
openFDA lists no recalls for product code GIQ.
Frequently asked questions
What is FDA product code GIQ?
GIQ is the FDA product code for hemoglobin s. It is a Class II device, regulated under 21 CFR 864.7415 and reviewed by the Hematology panel.
What device class is GIQ?
Class II, regulation 21 CFR 864.7415. Typical premarket route: 510(k).
How long does a 510(k) take for product code GIQ?
Across 3 cleared submissions the average was 198 days from receipt to decision (median 240).
Which companies have the most GIQ clearances?
Medicus Technologies, Inc. (1); Isolab, Inc. (1); Hf Scientific, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GIQ
- Run a recall and safety report across every GIQ manufacturer
- Watch product code GIQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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