JTA — Monitor, Microbial Growth Class I
FDA product code JTA covers "Monitor, Microbial Growth", a Class I medical device regulated under 21 CFR 866.2560. Submissions are reviewed by the Microbiology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JTA
- Device Class
- Class I
- Regulation Number
- 866.2560
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K954923 | becton dickinson diagnostic instrument systems | BACTEC FUNGAL MEDIUM | November 21, 1996 |
| K910835 | bd becton dickinson vacutainer systems preanalytic | BACTEC NR-860 | March 11, 1991 |
| K865021 | bd becton dickinson vacutainer systems preanalytic | BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM | February 6, 1987 |
| K853011 | bd becton dickinson vacutainer systems preanalytic | BACTEC NR-730 BACTERIAL DETECTION SYSTEM | July 30, 1985 |
| K842874 | american micro scan | RADIOMETRIC BLOOD CULTURE VIALS, AEROBE | September 12, 1984 |
| K842279 | bd becton dickinson vacutainer systems preanalytic | BECTEC NR-660 BACTERIAL DETECT SYS | July 20, 1984 |
| K833917 | marion laboratories | BAC-T-SCREEN | January 13, 1984 |
| K834264 | applied polytechnology | REVERSE-FLOW SYSTEM | January 13, 1984 |
| K810042 | bd becton dickinson vacutainer systems preanalytic | BACTEC BACTERIAL DETECTION SYSTEM: #5 | January 28, 1981 |
| K792575 | bd becton dickinson vacutainer systems preanalytic | BACTEC BACTERIAL DETECTION SYSTEM | December 27, 1979 |
| K790297 | abbott laboratories | DETECTION SYSTEM, MS-2 ELECTROCHEMICAL | April 26, 1979 |