Bact/Alert SN

FDA 510(k) K993421 · Organon Teknika Corp.

Substantially Equivalent

510(k) numberK993421

Submission

Device name
Bact/Alert SN
Applicant
Organon Teknika Corp.
Durham, NC, US
Received
October 12, 1999
Decision date
December 14, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MDB – System, Blood Culturing
Device class
Class I (low risk)
Regulation
21 CFR 866.2560
Specialty
Microbiology

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K161306BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialMDB · Traditional Becton Dickinson08/08/2016SE
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More from Becton, Dickinson and Company

510(k)DeviceDecision
K003104Bact/Alert CSRLJF · Traditional 10/20/2000SE
K000492Mda D-DimerDAP · Traditional 06/07/2000SE
K000378Bact/Alert MB Culture BottleMDB · Traditional 03/02/2000SE
K994343Bact/Alert SVMDB · Traditional 02/10/2000SE
K993423Bact/Alert SAMDB · Traditional 12/15/1999SE
K993576Bact/Alert MP Process BottleMDB · Traditional 12/14/1999SE
K992432Bact/Alert FNMDB · Traditional 09/24/1999SE
K983762Nuclisens CMV PP67LIN · Traditional 09/15/1999SE
K992401Bact/Alert PFMDB · Traditional 09/03/1999SE
K992400Bactalert FaMDB · Traditional 09/03/1999SE

Questions and answers

When was Bact/Alert SN cleared by the FDA?

Bact/Alert SN (K993421) received a 510(k) decision of Substantially Equivalent on December 14, 1999, 63 days after the submission was received.

What is the product code of K993421?

The FDA product code is MDB – System, Blood Culturing, a Class I (low risk) device regulated under 21 CFR 866.2560.