Bactec NR-860
FDA 510(k) K910835 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK910835
Submission
- Device name
- Bactec NR-860
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- February 27, 1991
- Decision date
- March 11, 1991
- 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 |
| 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 |
| 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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|---|---|---|
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| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Bactec NR-860 cleared by the FDA?
Bactec NR-860 (K910835) received a 510(k) decision of Substantially Equivalent on March 11, 1991, 12 days after the submission was received.
What is the product code of K910835?
The FDA product code is JTA – Monitor, Microbial Growth, a Class I (low risk) device regulated under 21 CFR 866.2560.