510(k) K883567
K883567 is an FDA 510(k) premarket notification submitted by Val Tech Diagnostics, Inc. for the device "HISTO-CHECK LEGIONELLA CONTROL SLIDES". The FDA issued a decision of Substantially Equivalent on Oct 6, 1988. The device falls under product code LJG (Quality Control Slides), a Class I device regulated under 21 CFR 866.2660. Val Tech Diagnostics, Inc. has 10 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 6, 1988
- Date Received
- Aug 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Quality Control Slides
- Device Class
- Class I
- Regulation Number
- 866.2660
- Review Panel
- MI
- Submission Type
- 510(k) Exempt