510(k) K944462
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 15, 1994
- Date Received
- September 12, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photometric Method, Iron (Non-Heme)
- Device Class
- Class I
- Regulation Number
- 862.1410
- Review Panel
- CH
- Submission Type