510(k) K844637
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 1985
- Date Received
- November 28, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hyaline Membrane Disease Assay
- Device Class
- Class III
- Regulation Number
- Review Panel
- CH
- Submission Type