Modification of Est Culture System II - Myco
FDA 510(k) K972756 · Accumed Intl., Inc.
510(k) numberK972756
Submission
- Device name
- Modification of Est Culture System II - Myco
- Applicant
- Accumed Intl., Inc.
Westlake, OH, US - Received
- May 30, 1997
- Decision date
- August 1, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MDB – System, Blood Culturing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2560
- Specialty
- Microbiology
Other 510(k)s with product code MDB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260213 | BD BACTEC FXI Culture SystemMDB · Traditional | BD Diagnostic Systems | 05/28/2026SE |
| K222591 | BD BACTEC Plus Aerobic/F Culture VialsMDB · Special | Becton, Dickinson and Company | 03/24/2023SE |
| K222559 | BD BACTEC Myco/F Lytic Culture VialsMDB · Traditional | Becton, Dickinson and Company | 03/24/2023SE |
| K190405 | BACT/ALERT MP Reagent SystemMDB · Traditional | bioMerieux, Inc. | 05/15/2019SE |
| K183166 | BacT/ALERT FA Plus; BacT/ALERT PF PlusMDB · Traditional | bioMerieux, Inc. | 02/11/2019SE |
| K173873 | BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic…MDB · Traditional | Becton, Dickinson and Company | 03/16/2018SE |
| K161816 | BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUOMDB · Traditional | bioMerieux, Inc. | 03/28/2017SE |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic…MDB · Traditional | Becton Dickinson | 02/09/2017SE |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialMDB · Traditional | Becton Dickinson | 08/08/2016SE |
| 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 |
|---|---|---|
| K984489 | Sensititre 18-24 Hour Susceptibility PlatesJWY · Traditional | 02/16/1999SE |
| K983306 | Sensititre 18-24 Hour Susceptibility Plates with GrepafloxacinLTT · Traditional | 12/18/1998SE |
| K983310 | Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional | 12/17/1998SE |
| K983309 | Sensititre 19 - 24 Hour Susceptibility Plates with LevofloxacinLTT · Traditional | 12/14/1998SE |
| K983301 | Sensititre 18-24 Hour Susceptibility Plates with TrovafloxacinJWY · Traditional | 11/25/1998SE |
| K982786 | Traccell 2000 Slide Mapping SystemJOY · Traditional | 10/16/1998SE |
| K972576 | Gram Positive Autoidentification Plates, Sensititre AP90LQL · Traditional | 01/22/1998SE |
| K964689 | Traccell 2000 Slide Mapping SystemJOY · Traditional | 08/18/1997SE |
| K965190 | Sensititre Haemophilus/Streptococcus Pneumoniae Mic PlateJWY · Traditional | 03/19/1997SE |
| K960366 | Sensititre 18 Hour Susceptibility PlatesLTT · Traditional | 04/09/1996SE |
Questions and answers
When was Modification of Est Culture System II - Myco cleared by the FDA?
Modification of Est Culture System II - Myco (K972756) received a 510(k) decision of Substantially Equivalent on August 1, 1997, 63 days after the submission was received.
What is the product code of K972756?
The FDA product code is MDB – System, Blood Culturing, a Class I (low risk) device regulated under 21 CFR 866.2560.