510(k) K890984
K890984 is an FDA 510(k) premarket notification submitted by Shandon, Inc. for the device "LINISTAIN SLS". The FDA issued a decision of Substantially Equivalent on April 4, 1989. The device falls under product code KIO (Slide Stainer, Immersion Type), a Class I device regulated under 21 CFR 864.3800. Shandon, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1989
- Date Received
- February 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Slide Stainer, Immersion Type
- Device Class
- Class I
- Regulation Number
- 864.3800
- Review Panel
- PA
- Submission Type