Reverse-Flow System
FDA 510(k) K834264 · Applied Polytechnology, Inc.
510(k) numberK834264
Submission
- Device name
- Reverse-Flow System
- Applicant
- Applied Polytechnology, Inc.
Mchenry, IL, US - Received
- December 8, 1983
- Decision date
- January 13, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTA – Monitor, Microbial Growth
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2560
- Specialty
- Microbiology
Other 510(k)s with product code JTA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954923 | Bactec Fungal MediumJTA · Traditional | Becton Dickinson Diagnostic Instrument Systems | 11/21/1996SE |
| K910835 | Bactec NR-860JTA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/11/1991SE |
| K865021 | Bactec(R) NR-660 High Performance SystemJTA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/06/1987SE |
| K853011 | Bactec NR-730 Bacterial Detection SystemJTA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/30/1985SE |
| K842874 | Radiometric Blood Culture Vials, AerobeJTA · Traditional | American Micro Scan | 09/12/1984SE |
| K842279 | Bectec NR-660 Bacterial Detect SysJTA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/20/1984SE |
| K833917 | Bac-T-ScreenJTA · Traditional | Marion Laboratories, Inc. | 01/13/1984SE |
| K810042 | Bactec Bacterial Detection System: #5JTA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 01/28/1981SE |
| K792575 | Bactec Bacterial Detection SystemJTA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/27/1979SE |
| K790297 | Detection System, MS-2 ElectrochemicalJTA · Traditional | Abbott Laboratories | 04/26/1979SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K860483 | Filtra-Check-UtiJXA · Traditional | 04/04/1986SE |
| K843834 | Bacteriuria Detect. Device Aptek IIJXA · Traditional | 11/29/1984SE |
| K843833 | Bacteriuria Detect Device, Multi SamplerJXA · Traditional | 11/29/1984SE |
| K843359 | Urine Transport KitJTW · Traditional | 09/27/1984SE |
| K843316 | Indole Spot Test Kit 270-25JTO · Traditional | 09/11/1984SE |
| K840257 | Rapid Immuno-Assay SysLLG · Traditional | 04/19/1984SE |
Questions and answers
When was Reverse-Flow System cleared by the FDA?
Reverse-Flow System (K834264) received a 510(k) decision of Substantially Equivalent on January 13, 1984, 36 days after the submission was received.
What is the product code of K834264?
The FDA product code is JTA – Monitor, Microbial Growth, a Class I (low risk) device regulated under 21 CFR 866.2560.