510(k) K024240

BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS by Bd — Product Code JSM

K024240 is an FDA 510(k) premarket notification submitted by Bd for the device "BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS". The FDA issued a decision of Substantially Equivalent on March 26, 2003. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Bd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2003
Date Received
December 23, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type