FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
K Number: K982315
·
Decision Nov 18, 1998
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
11
Applicant Total
3
Review Days
140
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Basic Information
- Device Name
- PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
- K Number
- K982315
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alexon - Trend, Inc.
- Date Received
- July 1, 1998
- Decision Date
- November 18, 1998
- 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 |
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