FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
K Number: K984596
·
Decision Mar 4, 1999
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
4
Review Days
66
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Basic Information
- Device Name
- VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIES
- K Number
- K984596
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zymetx, Inc.
- Date Received
- December 28, 1998
- Decision Date
- March 4, 1999
- Product Code
- GNR
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GNR | Antisera, Neutralization, Influenza Virus A, B, C | FDA class 1 | Microbiology |
Other Clearances by Zymetx, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982429 | ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES | Aug 25, 1998 | Substantially Equivalent |
| K971494 | VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES | Sep 10, 1997 | Substantially Equivalent |
| K950838 | VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES | Jun 17, 1996 | Substantially Equivalent |