510(k) K854724

CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE by Lifetrac, Inc. — Product Code KIZ

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