FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
K Number: K083175
·
Decision Jan 26, 2009
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
92
Review Days
90
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Basic Information
- Device Name
- BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
- K Number
- K083175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- October 28, 2008
- Decision Date
- January 26, 2009
- 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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