FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
K Number: K101533
·
Decision Aug 10, 2011
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
2
Review Days
433
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Basic Information
- Device Name
- EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
- K Number
- K101533
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tem Innovations GmbH
- Date Received
- June 3, 2010
- Decision Date
- August 10, 2011
- 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 Tem Innovations GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K201440 | ROTEM sigma Thromboelastometry System | Jul 8, 2022 | Substantially Equivalent |