Haemophilus Test Medium (HTM) Broth
FDA 510(k) K903425 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK903425
Submission
- Device name
- Haemophilus Test Medium (HTM) Broth
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- July 31, 1990
- Decision date
- August 22, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSO – Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1700
- Specialty
- Microbiology
Other 510(k)s with product code JSO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190553 | HardyCHROM CREJSO · Traditional | Hardy Diagnostics | 04/29/2019SE |
| K181092 | CHROMID CARBA agar (CARB)JSO · Traditional | Biomerieux S.A. | 07/06/2018SE |
| K171061 | MRSASelect IIJSO · Traditional | Bio-Rad | 12/28/2017SE |
| K162620 | Remel Spectra ESBLJSO · Traditional | Remel, Inc. | 05/01/2017SE |
| K160512 | HardyCHROM ESBLJSO · Traditional | Hardy Diagnostics | 11/15/2016SE |
| K162076 | chromID MRSAJSO · Traditional | bioMerieux, Inc. | 10/25/2016SE |
| K151688 | chromID MRSAJSO · Traditional | bioMerieux, Inc. | 03/11/2016SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | Bio-Rad | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | Bio-Rad | 10/21/2011SE |
| K102922 | Hardychrom MrsaJSO · Traditional | Hardy Diagnostics | 05/04/2011SE |
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| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Haemophilus Test Medium (HTM) Broth cleared by the FDA?
Haemophilus Test Medium (HTM) Broth (K903425) received a 510(k) decision of Substantially Equivalent on August 22, 1990, 22 days after the submission was received.
What is the product code of K903425?
The FDA product code is JSO – Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar, a Class II (moderate risk) device regulated under 21 CFR 866.1700.