510(k) K984596
- Device
- VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
- Applicant
- ZYMETX, INC.
- 510(k) number
- K984596
- Product code
- GNR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-03-04
- Date received
- 1998-12-28
- Regulation
- 866.3330
- Classification name
- Antisera, Neutralization, Influenza Virus A, B, C
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CRAIG D SHIMASAKI
- Address
- 800 Research Pkwy., Suite 100 Oklahoma City OK US 73104 73104
Source Documents#
Legacy Summary#
summary
FDA Review#
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