510(k) K950308
K950308 is an FDA 510(k) premarket notification submitted by Solarcare Technologies Corp,Inc. for the device "STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA". The FDA issued a decision of Substantially Equivalent on April 14, 1995. The device falls under product code JXS (Block, Cutting, Ent, Sterile), a Class I device regulated under 21 CFR 874.3540. Solarcare Technologies Corp,Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1995
- Date Received
- January 25, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Cutting, Ent, Sterile
- Device Class
- Class I
- Regulation Number
- 874.3540
- Review Panel
- EN
- Submission Type