510(k) K991597
K991597 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "COBAS INTEGRA AMIKACIN MAB". The FDA issued a decision of Substantially Equivalent on July 22, 1999. The device falls under product code LGJ (Fluorescence Polarization Immunoassay, Amibacin), a Class II device regulated under 21 CFR 862.3035. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 1999
- Date Received
- May 10, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorescence Polarization Immunoassay, Amibacin
- Device Class
- Class II
- Regulation Number
- 862.3035
- Review Panel
- TX
- Submission Type