510(k) K881379
K881379 is an FDA 510(k) premarket notification submitted by American Bionetics, Inc. for the device "WESBLOT RNP-SM TEST". The FDA issued a decision of Substantially Equivalent on May 16, 1988. The device falls under product code LKP (Anti-Sm Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. American Bionetics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1988
- Date Received
- April 1, 1988
- 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