510(k) K813523
K813523 is an FDA 510(k) premarket notification submitted by Techhnilab Instruments, Inc. for the device "ELECTRIC SELF STERILIZATION INOCUL. LOOP". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code LTB (Cyclosporine Radioimmunoassay), a Class II device regulated under 21 CFR 862.1235. Techhnilab Instruments, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1981
- Date Received
- December 16, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cyclosporine Radioimmunoassay
- Device Class
- Class II
- Regulation Number
- 862.1235
- Review Panel
- TX
- Submission Type