FDA product code OTQ: Research Use Only/Hematology Devices
OTQ is the FDA product code for research use only/hematology devices. It is a Not classified device, reviewed by the Hematology panel. Devices under OTQ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
For research use only and for products imported into the US only.
Classification
| Field | Value |
|---|---|
| Device name | Research Use Only/Hematology Devices |
| Device class | Not classified |
| Review panel | HE — Hematology |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for OTQ devices
openFDA lists no recalls for product code OTQ.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- Q4240 — Corecyte, for topical use only, per 0.5 cc
- Q4241 — Polycyte, for topical use only, per 0.5 cc
Frequently asked questions
What is FDA product code OTQ?
OTQ is the FDA product code for research use only/hematology devices. It is a Not classified device, reviewed by the Hematology panel.
What device class is OTQ?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code OTQ
- Run a recall and safety report across every OTQ manufacturer
- Watch product code OTQ 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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