510(k) K881477
K881477 is an FDA 510(k) premarket notification submitted by Stat Path for the device "HISTOGRIP & HISTOGRIP GOLD CONCENTRATE/PREDILUTED". The FDA issued a decision of Substantially Equivalent on April 18, 1988. The device falls under product code KEL (Adhesive, Albumin-Based), a Class I device regulated under 21 CFR 864.4010. Stat Path has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1988
- Date Received
- April 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adhesive, Albumin-Based
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type