510(k) K910210
- Device
- SLIDEX MENINGITE-KIT 5
- Applicant
- VITEK SYSTEMS, INC.
- 510(k) number
- K910210
- Product code
- GTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-12
- Date received
- 1991-01-15
- Regulation
- 866.3390
- Classification name
- Antisera, All Groups, N. Meningitidis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID K BROADWAY
- Address
- 595 Anglum Dr. Hazelwood MI US 63042 63042
FDA Registration Numbers#
- 1119779
- 3003750284
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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