510(k) K944056
K944056 is an FDA 510(k) premarket notification submitted by Solarcare Technologies Corp,Inc. for the device "AUTO-LYTE METHADONE DIA". The FDA issued a decision of Substantially Equivalent on December 29, 1994. The device falls under product code DJR (Enzyme Immunoassay, Methadone), a Class II device regulated under 21 CFR 862.3620. Solarcare Technologies Corp,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1994
- Date Received
- August 19, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Methadone
- Device Class
- Class II
- Regulation Number
- 862.3620
- Review Panel
- TX
- Submission Type