510(k) K760156
K760156 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "TEST, (IVDP) SMOOTHMUSCLE ANTIBODY". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code DBE (Antismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5120. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1976
- Date Received
- July 2, 1976
- 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