Mb/Bact Blood Culture Bottle
FDA 510(k) K983772 · Organon Teknika Corp.
510(k) numberK983772
Submission
- Device name
- Mb/Bact Blood Culture Bottle
- Applicant
- Organon Teknika Corp.
Durham, NC, US - Received
- October 26, 1998
- Decision date
- January 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic)MDB · Traditional | Becton, Dickinson and Company | 02/25/2016SE |
More from Becton, Dickinson and Company
| 510(k) | Device | Decision |
|---|---|---|
| K003104 | Bact/Alert CSRLJF · Traditional | 10/20/2000SE |
| K000492 | Mda D-DimerDAP · Traditional | 06/07/2000SE |
| K000378 | Bact/Alert MB Culture BottleMDB · Traditional | 03/02/2000SE |
| K994343 | Bact/Alert SVMDB · Traditional | 02/10/2000SE |
| K993423 | Bact/Alert SAMDB · Traditional | 12/15/1999SE |
| K993576 | Bact/Alert MP Process BottleMDB · Traditional | 12/14/1999SE |
| K993421 | Bact/Alert SNMDB · Traditional | 12/14/1999SE |
| K992432 | Bact/Alert FNMDB · Traditional | 09/24/1999SE |
| K983762 | Nuclisens CMV PP67LIN · Traditional | 09/15/1999SE |
| K992401 | Bact/Alert PFMDB · Traditional | 09/03/1999SE |
Questions and answers
When was Mb/Bact Blood Culture Bottle cleared by the FDA?
Mb/Bact Blood Culture Bottle (K983772) received a 510(k) decision of Substantially Equivalent on January 13, 1999, 79 days after the submission was received.
What is the product code of K983772?
The FDA product code is MDB – System, Blood Culturing, a Class I (low risk) device regulated under 21 CFR 866.2560.