FDA 510(k)
Substantially Equivalent
🇺🇸 United States
DIRECTIGEN NEISSERIA MENINGITIDIS
K Number: K830646
·
Decision May 27, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
632
Review Days
87
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Basic Information
- Device Name
- DIRECTIGEN NEISSERIA MENINGITIDIS
- K Number
- K830646
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- March 1, 1983
- Decision Date
- May 27, 1983
- Advisory Committee
- Unknown
- Review Advisory Committee
- MI
- Third Party
- N
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