Sysmex Automated Coagulation Analyzer, Model CA-6000
FDA 510(k) K992321 · Dade Behring, Inc.
510(k) numberK992321
Submission
- Device name
- Sysmex Automated Coagulation Analyzer, Model CA-6000
- Applicant
- Dade Behring, Inc.
Miami, FL, US - Received
- July 12, 1999
- Decision date
- September 17, 1999
- 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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Questions and answers
When was Sysmex Automated Coagulation Analyzer, Model CA-6000 cleared by the FDA?
Sysmex Automated Coagulation Analyzer, Model CA-6000 (K992321) received a 510(k) decision of Substantially Equivalent on September 17, 1999, 67 days after the submission was received.
What is the product code of K992321?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.