FDA product code GJZ: Cyanomethemoglobin Reagent And Standard Solution
GJZ is the FDA product code for cyanomethemoglobin reagent and standard solution. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel. FDA has cleared 2 510(k) submissions under GJZ, from 2 different applicants. The average 510(k) review took 37 days (median 37).
Classification
| Field | Value |
|---|---|
| Device name | Cyanomethemoglobin Reagent And Standard Solution |
| 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 GJZ clearance
Top GJZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tech-Co, Inc. | 1 | 1988-10-06 |
| Abbott Diagnostics | 1 | 1988-04-21 |
Most recent GJZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883683 | Tech-Co, Inc. | HEMOGLOBIN | 1988-10-06 | 38 |
| K881242 | Abbott Diagnostics | CELL-DYN RAPID-LYSE AND HEMOGLOBLIN | 1988-04-21 | 36 |
Recalls for GJZ devices
openFDA lists no recalls for product code GJZ.
Frequently asked questions
What is FDA product code GJZ?
GJZ is the FDA product code for cyanomethemoglobin reagent and standard solution. It is a Class II device, regulated under 21 CFR 864.7500 and reviewed by the Hematology panel.
What device class is GJZ?
Class II, regulation 21 CFR 864.7500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GJZ?
Across 2 cleared submissions the average was 37 days from receipt to decision (median 37).
Which companies have the most GJZ clearances?
Tech-Co, Inc. (1); Abbott Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GJZ
- Run a recall and safety report across every GJZ manufacturer
- Watch product code GJZ 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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