Artimicrobial Removal Device
FDA 510(k) K830372 · Marion Laboratories, Inc.
510(k) numberK830372
Submission
- Device name
- Artimicrobial Removal Device
- Applicant
- Marion Laboratories, Inc.
Walker, MI, US - Received
- February 4, 1983
- Decision date
- April 8, 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003104 | Bact/Alert CSRLJF · Traditional | Organon Teknika Corp. | 10/20/2000SE |
| K830363 | Bactec 170 Tryptic Soy Broth W/ResinsLJF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/24/1983SE |
| K822344 | Antimicrobial Removal Device (Ard)LJF · Traditional | Marion Laboratories, Inc. | 08/25/1982SE |
More from Marion Laboratories, Inc.
| 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 Artimicrobial Removal Device cleared by the FDA?
Artimicrobial Removal Device (K830372) received a 510(k) decision of Substantially Equivalent on April 8, 1983, 63 days after the submission was received.
What is the product code of K830372?
The FDA product code is LJF – Device, Antimicrobial Drug Removal, a Class I (low risk) device regulated under 21 CFR 866.2560.