510(k) K952791
- Device
- DIRECTIGEN MENINGITIS COMBO TEST
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- 510(k) number
- K952791
- Product code
- GTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-05-30
- Date received
- 1995-06-19
- Regulation
- 866.3390
- Classification name
- Antisera, 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
- JUDITH J SMITH
- Address
- P.O. Box 243 Cockeysville MD US 21030 21030
FDA Registration Numbers#
- 3003750284
- 1119779
Source Documents#
Legacy Summary#
summary
FDA Review#
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