510(k) K780949
K780949 is an FDA 510(k) premarket notification submitted by Monitor Science Corp. for the device "BIO-MONITOR AMIKACIN". The FDA issued a decision of Substantially Equivalent on August 14, 1978. The device falls under product code KLP (Amikacin Serum Assay), a Class II device regulated under 21 CFR 862.3035. Monitor Science Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 1978
- Date Received
- June 9, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Amikacin Serum Assay
- Device Class
- Class II
- Regulation Number
- 862.3035
- Review Panel
- TX
- Submission Type