Radiometric Blood Culture Vials, Aerobe
FDA 510(k) K842874 · American Micro Scan
510(k) numberK842874
Submission
- Device name
- Radiometric Blood Culture Vials, Aerobe
- Applicant
- American Micro Scan
Mchenry, IL, US - Received
- July 23, 1984
- Decision date
- September 12, 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
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| 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 |
| K842279 | Bectec NR-660 Bacterial Detect SysJTA · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/20/1984SE |
| K834264 | Reverse-Flow SystemJTA · Traditional | Applied Polytechnology, Inc. | 01/13/1984SE |
| 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 |
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| K864662 | Chlamydiae Fluor. AB Test for Detection in SmearsLJP · Traditional | 03/25/1987SE |
| K863776 | Microdilution Mic PanelsJWY · Traditional | 02/02/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | 01/05/1987SE |
| K864389 | Chlamydiae Flourescent Monoclonal Antibody TestLJP · Traditional | 12/04/1986SE |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | 09/30/1986SE |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | 09/11/1986SE |
| K862332 | Anaerobe Rapid Chromogenic Id PanelJSP · Traditional | 08/27/1986SE |
| K862140 | Microdilution PanelsJWY · Traditional | 07/16/1986SE |
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Questions and answers
When was Radiometric Blood Culture Vials, Aerobe cleared by the FDA?
Radiometric Blood Culture Vials, Aerobe (K842874) received a 510(k) decision of Substantially Equivalent on September 12, 1984, 51 days after the submission was received.
What is the product code of K842874?
The FDA product code is JTA – Monitor, Microbial Growth, a Class I (low risk) device regulated under 21 CFR 866.2560.