510(k) K761138
K761138 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "FA TISSUE FIXATIVE & WASH SET". The FDA issued a decision of Substantially Equivalent on January 6, 1978. The device falls under product code LDZ (Fixative, Alcohol Containing), a Class I device regulated under 21 CFR 864.4010. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 1978
- Date Received
- November 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fixative, Alcohol Containing
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type