BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits

FDA 510(k) K024240 · Bd

Substantially Equivalent

510(k) numberK024240

Submission

Device name
BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits
Applicant
Bd
Franklin Lakes, NJ, US
Received
December 23, 2002
Decision date
March 26, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JSM – Culture Media, Non-Propagating Transport
Device class
Class I (low risk)
Regulation
21 CFR 866.2390
Specialty
Microbiology

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Questions and answers

When was BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits cleared by the FDA?

BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits (K024240) received a 510(k) decision of Substantially Equivalent on March 26, 2003, 93 days after the submission was received.

What is the product code of K024240?

The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.