FDA 510(k)

BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771

K-Number: K091292 · 2009-08-25

ApplicantBecton, Dickinson and Company (BD)

Decision Date2009-08-25

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company (BD). It received FDA 510(k) clearance on 2009-08-25 under 510(k) number K091292. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771?

BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 is a medical device that received FDA 510(k) clearance on 2009-08-25. The listed applicant is Becton, Dickinson and Company (BD). The 510(k) number is K091292.

When did BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 receive FDA 510(k) clearance?

BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 received FDA 510(k) clearance on 2009-08-25, under 510(k) number K091292.

Who is the listed applicant for BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771?

The FDA 510(k) record lists Becton, Dickinson and Company (BD) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771?

The FDA product code for BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 is JKA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.