Antimicrobial Removal Device
FDA 510(k) K810613 · Marion Laboratories, Inc.
510(k) numberK810613
Submission
- Device name
- Antimicrobial Removal Device
- Applicant
- Marion Laboratories, Inc.
Walker, MI, US - Received
- March 6, 1981
- Decision date
- April 3, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MDB – System, Blood Culturing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2560
- Specialty
- Microbiology
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| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
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| 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 Antimicrobial Removal Device cleared by the FDA?
Antimicrobial Removal Device (K810613) received a 510(k) decision of Substantially Equivalent on April 3, 1981, 28 days after the submission was received.
What is the product code of K810613?
The FDA product code is MDB – System, Blood Culturing, a Class I (low risk) device regulated under 21 CFR 866.2560.