VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
FDA 510(k) clearance K984596 · decided 1999-03-04
Clearance details
- K-number
- K984596
- Device name
- VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
- Applicant
- Zymetx, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-28
- Decision date
- 1999-03-04
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- GNR
- Device class
- 1
- Regulation number
- 866.3330
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Oklahoma City, OK, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.