FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GENE-TRAK CAMPYLOBACTER ASSAY
K Number: K863270
·
Decision Aug 31, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
1
Review Days
371
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Basic Information
- Device Name
- GENE-TRAK CAMPYLOBACTER ASSAY
- K Number
- K863270
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Integrated Genetics
- Date Received
- August 25, 1986
- Decision Date
- August 31, 1987
- Product Code
- LQO
- 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 |
|---|---|---|---|
| LQO | Dna-Reagents, Campylobacter Spp. | FDA class 1 | Microbiology |
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