510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830646Substantially Equivalent

Directigen Neisseria Meningitidis

BD Becton Dickinson Vacutainer Systems Preanalytic, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830646 is the FDA 510(k) clearance record for DIRECTIGEN NEISSERIA MENINGITIDIS, cleared for Bd Becton Dickinson Vacutainer Systems Preanalytic on . FDA records list 632 510(k) clearances for Bd Becton Dickinson Vacutainer Systems Preanalytic, from to . As of , FDA records show no recalls naming K830646.

Clearance record

Decision date
Received
(87 days to decision)
Review panel
Unknown
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic 1875 Eye St. NW Suite 625, Washington DC
Third party review
No