510(k) K890542

MULTIWELL CULTURE PLATE INSERTS by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KIZ

K890542 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "MULTIWELL CULTURE PLATE INSERTS". The FDA issued a decision of Substantially Equivalent on February 14, 1989. The device falls under product code KIZ (Dish, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1989
Date Received
February 3, 1989
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