Product code JTA
- Device name
- Monitor, Microbial Growth
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2560
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954923 | BACTEC FUNGAL MEDIUM | Becton Dickinson Diagnostic Instrument Systems | 1996-11-21 |
| K910835 | BACTEC NR-860 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-03-11 |
| K865021 | BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-06 |
| K853011 | BACTEC NR-730 BACTERIAL DETECTION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-07-30 |
| K842874 | RADIOMETRIC BLOOD CULTURE VIALS, AEROBE | American Micro Scan | 1984-09-12 |
| K842279 | BECTEC NR-660 BACTERIAL DETECT SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-07-20 |
| K833917 | BAC-T-SCREEN | Marion Laboratories, Inc. | 1984-01-13 |
| K834264 | REVERSE-FLOW SYSTEM | Applied Polytechnology, Inc. | 1984-01-13 |
| K810042 | BACTEC BACTERIAL DETECTION SYSTEM: #5 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-28 |
| K792575 | BACTEC BACTERIAL DETECTION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-12-27 |
| K790297 | DETECTION SYSTEM, MS-2 ELECTROCHEMICAL | Abbott Laboratories | 1979-04-26 |
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| 60382902495606 | BD BACTEC™ Subculturing/Aerobic Venting Unit | BECTON, DICKINSON AND COMPANY | 2024-09-17 |
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| 30382902710562 | BD BBL™ Venting Unit | BECTON, DICKINSON AND COMPANY | 2018-05-25 |