510(k) K924395
- Device
- NEOTHROMITIN(R)
- Applicant
- BEHRING DIAGNOSTICS, INC.
- 510(k) number
- K924395
- Product code
- GPO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-12-01
- Date received
- 1992-08-31
- Regulation
- 866.3500
- Classification name
- Antigen, Cf, Typhus Fever Group
- Medical specialty
- Microbiology
- Review panel
- Hematology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH KICEINA
- Address
- 17 Chubb Way Somerville NJ US 08876 08876
FDA Registration Numbers#
- 1050190
Source Documents#
Legacy Summary#
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FDA Review#
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