JTX
8 FDA 510(k) clearances · Product code
48 daysmedian time to decision
189 days90th percentile
8clearances measured
FDA profile
- Official device name
- Transport Systems, Anaerobic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2012: 5
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 |
|---|---|---|
| ANAEROBIC ACCU-CULSHURE(TM) (K901645) | Medical Laboratory Automation Systems, Inc. | 1990-07-16 |
| ACUSON V328 AND C5432 TRANSDUCERS (K897151) | Acuson Corp. | 1990-07-03 |
| ACCU-CULSHURE TM (K882637) | Accu-Med Corp. | 1988-07-06 |
| BIO-BAG ENVIRONMENTAL CHAMBER (A & B) (K791724) | Marion Laboratories, Inc. | 1979-10-17 |
| STANDARDIZE TGCL & TGCH (K781376) | American Monitor Corp. | 1978-09-14 |
| ANASWAB (K780159) | Scott Laboratories, Inc. | 1978-02-13 |
| PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE (K761241) | Gibco Laboratories Life Technologies, Inc. | 1976-12-30 |
| SPECIMEN COLLECTOR, ANAEROBIC (K760063) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-08-03 |
Track JTX automatically
Every clearance here is in the API, with alerts when new ones post.