FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AggreGuide A-100 ADP
K Number: K181777
·
Decision Mar 29, 2019
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
37
Applicant Total
3
Review Days
269
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Basic Information
- Device Name
- AggreGuide A-100 ADP
- K Number
- K181777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5700
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aggredyne, Inc.
- Date Received
- July 3, 2018
- Decision Date
- March 29, 2019
- Product Code
- JOZ
- 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 |
|---|---|---|---|
| JOZ | System, Automated Platelet Aggregation | FDA class 2 | Hematology |
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