510(k) K941712
K941712 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS-FP REAGENTS AND CALIBRATORS". The FDA issued a decision of Substantially Equivalent on June 13, 1994. The device falls under product code LGJ (Fluorescence Polarization Immunoassay, Amibacin), 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 13, 1994
- Date Received
- April 6, 1994
- 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