Kidney, Artificial
FDA 510(k) K781153 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK781153
Submission
- Device name
- Kidney, Artificial
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Washington, DC, US - Received
- July 10, 1978
- Decision date
- October 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DJC – Thin Layer Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K253705 | Healgen® Accurate Oral Fluid Drug TestDJC · Traditional | Healgen Scientific,, LLC | 03/16/2026SE |
| K240287 | LYHER® Oral fluid Multi-Drug Test Kit (Cube)DJC · Traditional | Hangzhou Laihe Biotech Co., Ltd. | 03/18/2025SE |
| K180878 | BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test…DJC · Traditional | Shanghai Venture Bio-Tech Co., Ltd. | 12/17/2018SE |
| K181305 | OralTox Oral fluid Drug TestDJC · Traditional | Premier Biotech, Inc. | 09/20/2018SE |
| K171403 | OralTox Oral Fluid Drug TestDJC · Traditional | Premier Biotech, Inc. | 02/02/2018SE |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJC · Traditional | Assure Tech. (Hangzhou) Co, Ltd. | 07/06/2016SE |
| K132630 | Wondfo Oxazepam Urine Test (Bzo 200) and Wondfo Methamphetamine Urine Test (Met 300)DJC · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 09/27/2013SE |
| K080347 | Uniscan -Doa SystemDJC · Traditional | Taiwan Unison Biotech, Inc. | 10/09/2008SE |
| K060355 | Acro Biotech LLC Rapid Mdma Urine Test, Catalog MDMA0010000DJC · Traditional | Acro Biotech, LLC | 08/07/2006SE |
| K060896 | Modification to Ontrak Testcup II and Onsite CupkitDJC · Traditional | Varian, Inc. | 06/09/2006SE |
More from Varian, 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 Kidney, Artificial cleared by the FDA?
Kidney, Artificial (K781153) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 99 days after the submission was received.
What is the product code of K781153?
The FDA product code is DJC – Thin Layer Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.