510(k) K772151
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 1977
- Date Received
- November 15, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
- Device Class
- Class I
- Regulation Number
- 862.1795
- Review Panel
- CH
- Submission Type