← FDA Medical Device Classifications
Research Use Only/Pathology
OTU · Not classified · Unknown
Classification
- FDA Product Code
OTU- Device class
- Not classified
- Regulation
- —
- Review panel
- PA
- Medical specialty
- Unknown
- Submission type
- 7
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For research use only and for products imported into the US only.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 9
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown