510(k) K890042
K890042 is an FDA 510(k) premarket notification submitted by Stat Path for the device "MICROSCOPE SLIDES PRECOATED". The FDA issued a decision of Substantially Equivalent on January 13, 1989. The device falls under product code KEW (Slides, Microscope), a Class I device regulated under 21 CFR 864.3010. Stat Path has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1989
- Date Received
- January 5, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Slides, Microscope
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type