Bactec 170 Tryptic Soy Broth W/Resins
FDA 510(k) K830363 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK830363
Submission
- Device name
- Bactec 170 Tryptic Soy Broth W/Resins
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- February 4, 1983
- Decision date
- March 24, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LJF – Device, Antimicrobial Drug Removal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2560
- Specialty
- Microbiology
Other 510(k)s with product code LJF
More from Marion 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 170 Tryptic Soy Broth W/Resins cleared by the FDA?
Bactec 170 Tryptic Soy Broth W/Resins (K830363) received a 510(k) decision of Substantially Equivalent on March 24, 1983, 48 days after the submission was received.
What is the product code of K830363?
The FDA product code is LJF – Device, Antimicrobial Drug Removal, a Class I (low risk) device regulated under 21 CFR 866.2560.