FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IN FLUENZA B VIRUS
K Number: K843660
·
Decision Sep 26, 1985
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
17
Applicant Total
16
Review Days
374
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Basic Information
- Device Name
- IN FLUENZA B VIRUS
- K Number
- K843660
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Institute Virion , Ltd.
- Date Received
- September 17, 1984
- Decision Date
- September 26, 1985
- Product Code
- GNX
- 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 |
|---|---|---|---|
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | FDA class 1 | Microbiology |
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QUICKVUE INFLUENZA A+B
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Other Clearances by Institute Virion , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K862814 | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI | Sep 30, 1986 | Substantially Equivalent |
| K843665 | PARAINFLUENZA 1 | Sep 26, 1985 | Substantially Equivalent |
| K843649 | ADENOVIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843658 | H. SIMPLEX VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843662 | MEASLES VIRUS RUBEOLA | Sep 26, 1985 | Substantially Equivalent |
| K843657 | CYTOMEGALOVIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843667 | PARAINFLUENZA 3 | Sep 26, 1985 | Substantially Equivalent |
| K843673 | RESPIRATORY SYNCYTIAL VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843659 | INFLUENZA A2 VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843676 | VARICELLA/ZOSTER VIRUS | Sep 26, 1985 | Substantially Equivalent |