JTA
11 FDA 510(k) clearances · Product code
42 daysmedian time to decision
76 days90th percentile
11clearances measured
FDA profile
- Official device name
- Monitor, Microbial Growth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2560
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 2004: 11 · 2005: 19 · 2006: 5 · 2007: 9 · 2008: 11 · 2009: 4
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BACTEC FUNGAL MEDIUM (K954923) | Becton Dickinson Diagnostic Instrument Systems | 1996-11-21 |
| BACTEC NR-860 (K910835) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-03-11 |
| BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM (K865021) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1987-02-06 |
| BACTEC NR-730 BACTERIAL DETECTION SYSTEM (K853011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-07-30 |
| RADIOMETRIC BLOOD CULTURE VIALS, AEROBE (K842874) | American Micro Scan | 1984-09-12 |
| BECTEC NR-660 BACTERIAL DETECT SYS (K842279) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-07-20 |
| BAC-T-SCREEN (K833917) | Marion Laboratories, Inc. | 1984-01-13 |
| REVERSE-FLOW SYSTEM (K834264) | Applied Polytechnology, Inc. | 1984-01-13 |
| BACTEC BACTERIAL DETECTION SYSTEM: #5 (K810042) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-28 |
| BACTEC BACTERIAL DETECTION SYSTEM (K792575) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1979-12-27 |
| DETECTION SYSTEM, MS-2 ELECTROCHEMICAL (K790297) | Abbott Laboratories | 1979-04-26 |
Track JTA automatically
Every clearance here is in the API, with alerts when new ones post.