BACTEC MYCO/F LYTIC CULTURE VIALS
FDA 510(k) clearance K970333 · decided 1998-01-28
Clearance details
- K-number
- K970333
- Device name
- BACTEC MYCO/F LYTIC CULTURE VIALS
- Applicant
- Becton Dickinson Microbiology Systems
- Decision
- Substantially Equivalent
- Date received
- 1997-01-28
- Decision date
- 1998-01-28
- Days to decision
- 365 days
- Clearance type
- Traditional
- Product code
- MDB
- Device class
- 1
- Regulation number
- 866.2560
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sparks, MD, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
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| BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial (K173873) | Becton, Dickinson and Company | 2018-03-16 |
| BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO (K161816) | bioMerieux, Inc. | 2017-03-28 |
| BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161810) | Becton Dickinson | 2017-02-09 |
| BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic Vial (K161306) | Becton Dickinson | 2016-08-08 |
| BD BACTEC Peds Plus/F Culture Vials (plastic) (K151866) | Becton, Dickinson and Company | 2016-02-25 |
| BD BACTEC PLUS ANAEROBIC/F (PLASTIC) (K141810) | Becton, Dickinson and Company | 2014-12-10 |
| BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) (K123903) | Becton, Dickinson & CO | 2013-05-13 |
Recalls involving this device
No recalls on record reference this clearance.