510(k) K954830
K954830 is an FDA 510(k) premarket notification submitted by Orgentec for the device "ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY". The FDA issued a decision of Substantially Equivalent on May 8, 1996. The device falls under product code LKP (Anti-Sm Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Orgentec has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1996
- Date Received
- October 20, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Sm Antibody, Antigen And Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type