510(k) K882881
K882881 is an FDA 510(k) premarket notification submitted by Sakura Finetek U.S.A., Inc. for the device "SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER". The FDA issued a decision of Substantially Equivalent on July 28, 1988. The device falls under product code KES (Coverslips, Microscope Slide), a Class I device regulated under 21 CFR 864.3010. Sakura Finetek U.S.A., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 1988
- Date Received
- July 11, 1988
- 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