FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
K Number: K191807
·
Decision Oct 25, 2019
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
14
Applicant Total
2
Review Days
112
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Basic Information
- Device Name
- ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device
- K Number
- K191807
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5180
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ALPCO
- Date Received
- July 5, 2019
- Decision Date
- October 25, 2019
- Product Code
- NXO
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| NXO | Calprotectin, Fecal | FDA class 2 | Immunology |
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Other Clearances by ALPCO
| K Number | Device Name | ||
|---|---|---|---|
| K220763 | ALPCO Calprotectin Immunoturbidimetric Assay | Apr 13, 2023 | Substantially Equivalent |