510(k) K920274
- Device
- DIRECTIGEN NEISSERIA MENINGITIDIS TEST
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K920274
- Product code
- GTI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-03-18
- Date received
- 1992-01-22
- Regulation
- 866.3390
- Classification name
- Antisera, Fluorescent, All Groups, N. Meningitidis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT E JAMES
- Address
- P.O. Box 243 Cockeysville MD US 21030 21030
Source Documents#
Legacy Summary#
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FDA Review#
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