510(k) K800228
K800228 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT". The FDA issued a decision of Substantially Equivalent on February 21, 1980. The device falls under product code DBE (Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5120. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 1980
- Date Received
- February 5, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5120
- Review Panel
- IM
- Submission Type