510(k) K840647
K840647 is an FDA 510(k) premarket notification submitted by Beckman Instruments, Inc. for the device "AMIKACIN REAGENT TEST KIT". The FDA issued a decision of Substantially Equivalent on April 2, 1984. The device falls under product code LDN (Enzymatic Radiochemical Assay, Amikacin), a Class II device regulated under 21 CFR 862.3035. Beckman Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 1984
- Date Received
- February 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Radiochemical Assay, Amikacin
- Device Class
- Class II
- Regulation Number
- 862.3035
- Review Panel
- TX
- Submission Type