Bac-T-Screen
FDA 510(k) K833917 · Marion Laboratories, Inc.
510(k) numberK833917
Submission
- Device name
- Bac-T-Screen
- Applicant
- Marion Laboratories, Inc.
Mchenry, IL, US - Received
- November 14, 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 |
| K834264 | Reverse-Flow SystemJTA · Traditional | Applied Polytechnology, 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 |
|---|---|---|
| K883391 | Polymer Adhesive BandageNAD · Traditional | 03/23/1989SN |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | 07/05/1988SE |
| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K874553 | Envisan PasteKOZ · Traditional | 12/18/1987SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
Questions and answers
When was Bac-T-Screen cleared by the FDA?
Bac-T-Screen (K833917) received a 510(k) decision of Substantially Equivalent on January 13, 1984, 60 days after the submission was received.
What is the product code of K833917?
The FDA product code is JTA – Monitor, Microbial Growth, a Class I (low risk) device regulated under 21 CFR 866.2560.