510(k) K964670
K964670 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN". The FDA issued a decision of Substantially Equivalent on February 4, 1997. The device falls under product code LFW (Fluorescence Polarization Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 1997
- Date Received
- November 21, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorescence Polarization Immunoassay, Tobramycin
- Device Class
- Class II
- Regulation Number
- 862.3900
- Review Panel
- TX
- Submission Type