Thrombelastograph Coagulation Analyzer 3000S
FDA 510(k) K954437 · Haemoscope Corp.
510(k) numberK954437
Submission
- Device name
- Thrombelastograph Coagulation Analyzer 3000S
- Applicant
- Haemoscope Corp.
Skokie, IL, US - Received
- September 22, 1995
- Decision date
- January 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GKP – Instrument, Coagulation, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
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| K160276 | Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS)GKP · Special | Instrumentation Laboratory CO | 03/03/2016SE |
| K150877 | Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750…GKP · Traditional | Instrumentation Laboratory CO | 12/13/2015SE |
| K091980 | Acl Top 700 LasGKP · Special | Instrumentation Laboratory CO | 09/22/2009SE |
| K073377 | Acl Top (with System Software V3.0.0)GKP · Traditional | Instrumentation Laboratory CO | 05/04/2008SE |
| K063679 | Acl TopGKP · Special | Instrumentation Laboratory CO | 01/12/2007SE |
| K033414 | Acl Top Model, TopGKP · Abbreviated | Instrumentation Laboratory CO | 01/12/2004SE |
| K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…GKP · Traditional | Dade Behring, Inc. | 09/08/2003SE |
| K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinGKP · Traditional | Fisher Diagnostics | 12/09/2002SE |
More from Fisher Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K062604 | Rapidteg Teg-Act TestJBP · Traditional | 01/31/2007SE |
| K041502 | Thrombelastograph (Teg) Platelet Mapping AssayJOZ · Traditional | 09/01/2004SE |
| K002177 | Thrombelastograph Coagulation Analyzer TEG-5000 SeriesJPA · Traditional | 09/14/2000SE |
| K993678 | Thrombelastograph Coagulation Analyzer Teg - 5000 SeriesJPA · Traditional | 05/05/2000SE |
| K904204 | ThrombelastographGKP · Traditional | 11/01/1990SE |
| K895844 | Thrombelastograph(R)GKP · Traditional | 10/24/1989SE |
Questions and answers
When was Thrombelastograph Coagulation Analyzer 3000S cleared by the FDA?
Thrombelastograph Coagulation Analyzer 3000S (K954437) received a 510(k) decision of Substantially Equivalent on January 30, 1996, 130 days after the submission was received.
What is the product code of K954437?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.