FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hemochron Signature Elite
K Number: K193041
·
Decision Nov 22, 2019
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
3
Review Days
22
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Basic Information
- Device Name
- Hemochron Signature Elite
- K Number
- K193041
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Accriva Diagnostics, Inc.
- Date Received
- October 31, 2019
- Decision Date
- November 22, 2019
- Product Code
- JPA
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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Other Clearances by Accriva Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K223352 | Tenderfoot | Mar 2, 2023 | Substantially Equivalent |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 | Dec 29, 2021 | Substantially Equivalent |