510(k) K854724
K854724 is an FDA 510(k) premarket notification submitted by Lifetrac, Inc. for the device "CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE". The FDA issued a decision of Substantially Equivalent on December 13, 1985. The device falls under product code KIZ (Dish, Tissue Culture), a Class I device regulated under 21 CFR 864.2240.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1985
- Date Received
- November 22, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dish, Tissue Culture
- Device Class
- Class I
- Regulation Number
- 864.2240
- Review Panel
- PA
- Submission Type