Investigational Use Only - Clinical Chemistry
The Investigational Use Only - Clinical Chemistry product code is assigned to clinical chemistry devices that are for investigational use only and for products imported into the United States only; these devices have not completed the FDA's standard device classification process. The device is currently not classified (Class N) and has no assigned regulation number or medical specialty description. This code enables the importation of uncleared investigational clinical chemistry devices for research purposes. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PDA
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 7
Device Characteristics
Definition
Investigational use only and for products imported into the US only.
Unclassified Reason
6
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.