510(k) K822657
K822657 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "EMIT-AMD AMIKACIN ASSAY". The FDA issued a decision of Substantially Equivalent on September 28, 1982. The device falls under product code KLQ (Radioimmunoassay, Amikacin), a Class II device regulated under 21 CFR 862.3035. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1982
- Date Received
- September 3, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Amikacin
- Device Class
- Class II
- Regulation Number
- 862.3035
- Review Panel
- TX
- Submission Type