FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
K Number: K954437
·
Decision Jan 30, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
48
Applicant Total
7
Review Days
130
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Basic Information
- Device Name
- THROMBELASTOGRAPH COAGULATION ANALYZER 3000S
- K Number
- K954437
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Haemoscope Corp.
- Date Received
- September 22, 1995
- Decision Date
- January 30, 1996
- Product Code
- GKP
- 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 |
|---|---|---|---|
| GKP | Instrument, Coagulation, Automated | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKP), ordered by most recent decision date.
ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)
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FDA Class 2
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ACL TOP Family 70 Series
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ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP 700 LAS
FDA 510(k)
FDA Class 2
·Hematology
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
FDA 510(k)
FDA Class 2
·Hematology
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 |
| K002177 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES | Sep 14, 2000 | Substantially Equivalent |
| K993678 | THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES | May 5, 2000 | Substantially Equivalent |
| K904204 | THROMBELASTOGRAPH | Nov 1, 1990 | Substantially Equivalent |
| K895844 | THROMBELASTOGRAPH(R) | Oct 24, 1989 | Substantially Equivalent |