FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇭 Switzerland
COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI
K Number: K862814
·
Decision Sep 30, 1986
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
11
Applicant Total
16
Review Days
68
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Basic Information
- Device Name
- COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI
- K Number
- K862814
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Institute Virion , Ltd.
- Date Received
- July 24, 1986
- Decision Date
- September 30, 1986
- Product Code
- LQP
- 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 |
|---|---|---|---|
| LQP | Campylobacter Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQP), ordered by most recent decision date.
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FDA 510(k)
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CAMPYLOBACTER CHEK
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Institute Virion , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K843676 | VARICELLA/ZOSTER VIRUS | Sep 26, 1985 | Substantially Equivalent |