FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
K Number: K002177
·
Decision Sep 14, 2000
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
7
Review Days
57
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Basic Information
- Device Name
- THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
- K Number
- K002177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Haemoscope Corp.
- Date Received
- July 19, 2000
- Decision Date
- September 14, 2000
- 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 Haemoscope Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K062604 | RAPIDTEG TEG-ACT TEST | Jan 31, 2007 | Substantially Equivalent |
| K041502 | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | Sep 1, 2004 | Substantially Equivalent |
| K993678 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES | May 5, 2000 | Substantially Equivalent |
| K954437 | THROMBELASTOGRAPH COAGULATION ANALYZER 3000S | Jan 30, 1996 | Substantially Equivalent |
| K904204 | THROMBELASTOGRAPH | Nov 1, 1990 | Substantially Equivalent |
| K895844 | THROMBELASTOGRAPH(R) | Oct 24, 1989 | Substantially Equivalent |