FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASCA-CHEK
K Number: K071711
·
Decision Nov 7, 2007
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
5
Review Days
138
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Basic Information
- Device Name
- ASCA-CHEK
- K Number
- K071711
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5785
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techlab Inc., Corporate Research Center
- Date Received
- June 22, 2007
- Decision Date
- November 7, 2007
- Product Code
- NBT
- 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 |
|---|---|---|---|
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | FDA class 2 | Immunology |
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