FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
K Number: K201778
·
Decision Jan 8, 2021
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
5
Applicant Total
883
Review Days
192
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Basic Information
- Device Name
- i-STAT TBI Plasma cartridge with the i-STAT Alinity System
- K Number
- K201778
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5830
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- June 30, 2020
- Decision Date
- January 8, 2021
- Product Code
- QAT
- 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 |
|---|---|---|---|
| QAT | Brain Trauma Assessment Test | FDA class 2 | Immunology |
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