510(k) K823747
K823747 is an FDA 510(k) premarket notification submitted by Corning Medical & Scientific for the device "24 CELL WELLS TISSUE CULTURE". The FDA issued a decision of Substantially Equivalent on January 5, 1983. The device falls under product code KJG (Tube, Tissue Culture), a Class I device regulated under 21 CFR 864.3010. Corning Medical & Scientific has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1983
- Date Received
- December 13, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Tissue Culture
- Device Class
- Class I
- Regulation Number
- 864.3010
- Review Panel
- PA
- Submission Type