FDA product code KQH: Red-Cell Indices
KQH is the FDA product code for red-cell indices. It is a Class II device, regulated under 21 CFR 864.5300 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under KQH. The average 510(k) review took 38 days (median 38).
Classification
| Field | Value |
|---|---|
| Device name | Red-Cell Indices |
| Device class | Class II |
| Regulation | 21 CFR 864.5300 |
| 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 KQH clearance
Top KQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| V.Marc, A Div. of Pictorial, Inc. | 1 | 1986-07-10 |
Most recent KQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K862089 | V.Marc, A Div. of Pictorial, Inc. | V-MARC 88A COMPUTER | 1986-07-10 | 38 |
Recalls for KQH devices
openFDA lists no recalls for product code KQH.
Frequently asked questions
What is FDA product code KQH?
KQH is the FDA product code for red-cell indices. It is a Class II device, regulated under 21 CFR 864.5300 and reviewed by the Hematology panel.
What device class is KQH?
Class II, regulation 21 CFR 864.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code KQH?
Across 1 cleared submissions the average was 38 days from receipt to decision (median 38).
Which companies have the most KQH clearances?
V.Marc, A Div. of Pictorial, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KQH
- Run a recall and safety report across every KQH manufacturer
- Watch product code KQH 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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