510(k) K823747

24 CELL WELLS TISSUE CULTURE by Corning Medical & Scientific — Product Code KJG

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