Bactec Pyrazinamide Susceptibility Test
FDA 510(k) K895362 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK895362
Submission
- Device name
- Bactec Pyrazinamide Susceptibility Test
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- August 29, 1989
- Decision date
- December 1, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTT – Susceptibility Test Powders, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code JTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983310 | Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional | Accumed Intl., Inc. | 12/17/1998SE |
| K935805 | Pasco Mic and Mic/Id PanelsJTT · Traditional | Pasco Laboratories, Inc. | 06/13/1994SE |
| K880574 | Modified Imipenem Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 05/04/1988SE |
| K872081 | Cipro (TM) Diagnostic PowderJTT · Traditional | Miles Pharmaceuticals | 06/15/1987SE |
| K864442 | Norfloxacin Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 12/11/1986SE |
| K860031 | Gen Diagnostics' Imipenem 10 MCG Susceptibity DiskJTT · Traditional | Organon Teknika Corp. | 03/06/1986SE |
| K855207 | Imipenem 10 MCG Sensitivity DiscsJTT · Traditional | Difco Laboratories, Inc. | 03/06/1986SE |
| K855106 | Imipenem 10 MCG Sensi-Disc,Cat. # 31644/31645JTT · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/06/1986SE |
| K855071 | Imipenem Susceptibility PowderJTT · Traditional | Merck, Sharp & Dohme | 03/06/1986SE |
| K830758 | Azlin Azlocilin Sodium-Diag. ReagentJTT · Traditional | Miles Laboratories, Inc. | 05/25/1983SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003062 | Bactec Mgit 960 Sir KitsMJA · Traditional | 06/06/2001SE |
| K003553 | 0.9% Sodium Chloride Injection, Usp BD Pre-Filled Flush SyringeFOZ · Traditional | 03/21/2001SE |
| 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 Pyrazinamide Susceptibility Test cleared by the FDA?
Bactec Pyrazinamide Susceptibility Test (K895362) received a 510(k) decision of Substantially Equivalent on December 1, 1989, 94 days after the submission was received.
What is the product code of K895362?
The FDA product code is JTT – Susceptibility Test Powders, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.