510(k) K761152
K761152 is an FDA 510(k) premarket notification submitted by Advanced Biomedical Methods, Inc. for the device "S-UREA-N, IN VITRO DIAG FOR BUN". The FDA issued a decision of Substantially Equivalent on December 9, 1976. The device falls under product code CDL (Berthelot Indophenol, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Advanced Biomedical Methods, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1976
- Date Received
- November 29, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Berthelot Indophenol, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type