510(k) K852317
K852317 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on June 25, 1985. The device falls under product code KLQ (Radioimmunoassay, Amikacin), a Class II device regulated under 21 CFR 862.3035. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 1985
- Date Received
- May 31, 1985
- 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