510(k) K934376
K934376 is an FDA 510(k) premarket notification submitted by Solarcare, Inc. for the device "STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA". The FDA issued a decision of Substantially Equivalent on December 7, 1993. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Solarcare, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1993
- Date Received
- September 9, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Barbiturate
- Device Class
- Class II
- Regulation Number
- 862.3150
- Review Panel
- TX
- Submission Type