FDA product code GIG: Hemoglobinometer
GIG is the FDA product code for hemoglobinometer. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under GIG, from 3 different applicants. The average 510(k) review took 106 days (median 48).
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobinometer |
| Device class | Class II |
| Regulation | 21 CFR 864.7500 |
| 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 GIG clearance
Top GIG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Randox Laboratories, Ltd. | 1 | 1997-12-08 |
| Artel, Inc. | 1 | 1994-03-31 |
| The Dow Chemical Co. | 1 | 1977-07-21 |
Most recent GIG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K973995 | Randox Laboratories, Ltd. | RANDOX BILIRUBIN | 1997-12-08 | 48 |
| K933836 | Artel, Inc. | HBM HEMOGLOBINOMETER | 1994-03-31 | 238 |
| K771101 | The Dow Chemical Co. | HEMOGLOBIN ANALYZER & PERFORM. CHECK SET | 1977-07-21 | 31 |
Recalls for GIG devices
openFDA lists no recalls for product code GIG.
Frequently asked questions
What is FDA product code GIG?
GIG is the FDA product code for hemoglobinometer. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel.
What device class is GIG?
Class II, regulation 21 CFR 864.7500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GIG?
Across 3 cleared submissions the average was 106 days from receipt to decision (median 48).
Which companies have the most GIG clearances?
Randox Laboratories, Ltd. (1); Artel, Inc. (1); The Dow Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GIG
- Run a recall and safety report across every GIG manufacturer
- Watch product code GIG 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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