Thrombelastograph Coagulation Analyzer TEG-5000 Series
FDA 510(k) K002177 · Haemoscope Corp.
510(k) numberK002177
Submission
- Device name
- Thrombelastograph Coagulation Analyzer TEG-5000 Series
- Applicant
- Haemoscope Corp.
Skokie, IL, US - Received
- July 19, 2000
- Decision date
- September 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JPA – System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | Haemonetics Corporation | 03/29/2024SE |
| K233790 | Acl Top 970 CLJPA · Special | Instrumentation Laboratory | 12/29/2023SE |
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| K212183 | STA R Max 3, STA Compact Max 3JPA · Traditional | Diagnostica Stago S.A.S | 06/07/2023SE |
| K201440 | ROTEM sigma Thromboelastometry SystemJPA · Traditional | Tem Innovations GmbH | 07/08/2022SE |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…JPA · Traditional | Accriva Diagnostics, Inc. | 12/29/2021SE |
More from Accriva Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K062604 | Rapidteg Teg-Act TestJBP · Traditional | 01/31/2007SE |
| K041502 | Thrombelastograph (Teg) Platelet Mapping AssayJOZ · Traditional | 09/01/2004SE |
| K993678 | Thrombelastograph Coagulation Analyzer Teg - 5000 SeriesJPA · Traditional | 05/05/2000SE |
| K954437 | Thrombelastograph Coagulation Analyzer 3000SGKP · Traditional | 01/30/1996SE |
| K904204 | ThrombelastographGKP · Traditional | 11/01/1990SE |
| K895844 | Thrombelastograph(R)GKP · Traditional | 10/24/1989SE |
Questions and answers
When was Thrombelastograph Coagulation Analyzer TEG-5000 Series cleared by the FDA?
Thrombelastograph Coagulation Analyzer TEG-5000 Series (K002177) received a 510(k) decision of Substantially Equivalent on September 14, 2000, 57 days after the submission was received.
What is the product code of K002177?
The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.