Ard(Tm) Antimicrobial Removal Device
FDA 510(k) K911771 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK911771
Submission
- Device name
- Ard(Tm) Antimicrobial Removal Device
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- April 19, 1991
- Decision date
- July 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LJK – Antisera, If, Toxoplasma Gondii
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3780
- Specialty
- Microbiology
Other 510(k)s with product code LJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974261 | Accurun 135 Toxoplasma Igg Positive ControlLJK · Traditional | Boston Biomedica, Inc. | 12/11/1997SE |
| K861122 | The Golden Quad Test (Toxo)LJK · Traditional | Microbiological Research Corp. | 02/02/1987SE |
| K861460 | Solid State Continuous Flow Control Model W/K101LJK · Traditional | Widran Urological Group, Ltd. | 05/02/1986SE |
| K832069 | Toxo Ipa Kit Ian Indirect FluorescentLJK · Traditional | Bionetic Laboratory Products | 09/26/1983SE |
| K822605 | Toxoplasma Gondii Antibody IggLJK · Traditional | Immulok, Inc. | 10/27/1982SE |
More from Immulok, 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 Ard(Tm) Antimicrobial Removal Device cleared by the FDA?
Ard(Tm) Antimicrobial Removal Device (K911771) received a 510(k) decision of Substantially Equivalent on July 1, 1991, 73 days after the submission was received.
What is the product code of K911771?
The FDA product code is LJK – Antisera, If, Toxoplasma Gondii, a Class II (moderate risk) device regulated under 21 CFR 866.3780.