FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
i-STAT Hematocrit test with i-STAT Alinity System
K Number: K163342
·
Decision Aug 22, 2017
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
14
Applicant Total
883
Review Days
266
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Basic Information
- Device Name
- i-STAT Hematocrit test with i-STAT Alinity System
- K Number
- K163342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- November 29, 2016
- Decision Date
- August 22, 2017
- Product Code
- JPI
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JPI | Device, Hematocrit Measuring | FDA class 2 | Hematology |
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