FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E. HISTOLYTICA QUIK CHEK
K Number: K170728
·
Decision Jun 7, 2017
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
17
Applicant Total
3
Review Days
90
Basic Information
- Device Name
- E. HISTOLYTICA QUIK CHEK
- K Number
- K170728
- 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.
- Date Received
- March 9, 2017
- Decision Date
- June 7, 2017
- Product Code
- KHW
- 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 |
|---|---|---|---|
| KHW | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. | FDA class 2 | Microbiology |
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