Sysmex CA-6000
FDA 510(k) K964139 · Dade Intl., Inc.
510(k) numberK964139
Submission
- Device name
- Sysmex CA-6000
- Applicant
- Dade Intl., Inc.
Miami, FL, US - Received
- October 15, 1996
- Decision date
- February 6, 1997
- 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
Other 510(k)s with product code GKP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550…GKP · Special | Instrumentation Laboratory (IL) Co. | 08/16/2024SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | Instrumentation Laboratory Company | 06/21/2023SE |
| 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 |
|---|---|---|
| K974343 | Dade InnovinGJS · Traditional | 07/22/1998SE |
| K970505 | Dade PFA-100 Platelet Function Analyzer/Pfa Collagen/Epinephrine Test Cartridge/Pfa…JOZ · Traditional | 11/17/1997SE |
| K973974 | Dade Tru-Liquid Cardiac ControlJJT · Traditional | 11/06/1997SE |
| K973668 | Cardiac Troponin-I (Trop) CalibratorJIT · Traditional | 10/20/1997SE |
| K972524 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 09/08/1997SE |
| K972782 | Dade Stratus Ck-Mb Fluorometric Enzyme ImmunoassayJHX · Traditional | 08/15/1997SE |
| K972287 | Dade Tru-Liquid Bilirubin ControlJJX · Traditional | 07/07/1997SE |
| K964660 | Paramax Cholesterol ReagentCHH · Traditional | 06/04/1997SE |
| K970676 | Dried Gram-Negative Mic/Combo PanelsJWY · Traditional | 05/02/1997SE |
| K964715 | Paramax Salicylate ReagentDKJ · Traditional | 04/25/1997SE |
Questions and answers
When was Sysmex CA-6000 cleared by the FDA?
Sysmex CA-6000 (K964139) received a 510(k) decision of Substantially Equivalent on February 6, 1997, 114 days after the submission was received.
What is the product code of K964139?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.