FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Q-FEVER
K Number: K843672
·
Decision Aug 8, 1985
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
0
Applicant Total
16
Review Days
325
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Basic Information
- Device Name
- Q-FEVER
- K Number
- K843672
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3500
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Institute Virion , Ltd.
- Date Received
- September 17, 1984
- Decision Date
- August 8, 1985
- Product Code
- GPS
- 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 |
|---|---|---|---|
| GPS | Antigen, Cf, Q Fever | FDA class 1 | Microbiology |
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 |
| K843660 | IN FLUENZA B VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843673 | RESPIRATORY SYNCYTIAL VIRUS | Sep 26, 1985 | Substantially Equivalent |
| K843659 | INFLUENZA A2 VIRUS | Sep 26, 1985 | Substantially Equivalent |