FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
K Number: K103673
·
Decision Aug 18, 2011
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
26
Applicant Total
5
Review Days
245
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Basic Information
- Device Name
- GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
- K Number
- K103673
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techlab Inc., Corporate Research Center
- Date Received
- December 16, 2010
- Decision Date
- August 18, 2011
- Product Code
- MHI
- 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 |
|---|---|---|---|
| MHI | Giardia Spp. | FDA class 2 | Microbiology |
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