BD MAX Enteric Viral Panel
FDA 510(k) K220607 · Becton, Dickinson and Company
Submission
- Device name
- BD MAX Enteric Viral Panel
- Applicant
- Becton, Dickinson and Company
Sparks, MD, US - Received
- March 2, 2022
- Decision date
- September 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3990
- Specialty
- Microbiology
A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal…
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Questions and answers
When was BD MAX Enteric Viral Panel cleared by the FDA?
BD MAX Enteric Viral Panel (K220607) received a 510(k) decision of Substantially Equivalent on September 21, 2022, 203 days after the submission was received.
What is the product code of K220607?
The FDA product code is PCH – Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3990.