FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Carbon Dioxide Reagent Set
K Number: K170200
·
Decision Jun 1, 2017
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
85
Applicant Total
4
Review Days
129
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Basic Information
- Device Name
- Carbon Dioxide Reagent Set
- K Number
- K170200
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Teco Diagnostics, Inc.
- Date Received
- January 23, 2017
- Decision Date
- June 1, 2017
- Product Code
- KHS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | FDA class 2 | Clinical Chemistry |
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