510(k) K852319
K852319 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS". The FDA issued a decision of Substantially Equivalent on June 25, 1985. The device falls under product code LAN (Enzyme Immunoassay, N-Acetylprocainamide), a Class II device regulated under 21 CFR 862.3320. 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
- Enzyme Immunoassay, N-Acetylprocainamide
- Device Class
- Class II
- Regulation Number
- 862.3320
- Review Panel
- TX
- Submission Type