510(k) K945195
K945195 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN ONLINE PROPOXPHENE". The FDA issued a decision of Substantially Equivalent on December 9, 1994. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1994
- Date Received
- October 24, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Propoxyphene
- Device Class
- Class II
- Regulation Number
- 862.3700
- Review Panel
- TX
- Submission Type