510(k) K944372
K944372 is an FDA 510(k) premarket notification submitted by Solarcare, Inc. for the device "STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA". The FDA issued a decision of Substantially Equivalent on February 8, 1995. The device falls under product code JXN (Enzyme Immunoassay, Propoxyphene), a Class II device regulated under 21 CFR 862.3700. Solarcare, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 1995
- Date Received
- September 7, 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