← FDA Medical Device Classifications
Chemiluminescent Immunoassay System
PKM · Not classified · Unknown
Classification
- FDA Product Code
PKM- Device class
- Not classified
- Regulation
- —
- Review panel
- TX
- Medical specialty
- Unknown
- Submission type
- 3
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 1
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown