510(k) K771925
K771925 is an FDA 510(k) premarket notification submitted by Harleco for the device "KRYSTALONR LIQ. MOUNTING MED.&COVERSLIP". The FDA issued a decision of Substantially Equivalent on November 2, 1977. The device falls under product code KES (Coverslips, Microscope Slide), a Class I device regulated under 21 CFR 864.3010. Harleco has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 2, 1977
- Date Received
- October 14, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coverslips, Microscope Slide
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type