Sysmex Automated Coagulation Analyzer, Model CA-1500
FDA 510(k) K010494 · Dade Behring, Inc.
510(k) numberK010494
Submission
- Device name
- Sysmex Automated Coagulation Analyzer, Model CA-1500
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- February 20, 2001
- Decision date
- May 1, 2001
- 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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Questions and answers
When was Sysmex Automated Coagulation Analyzer, Model CA-1500 cleared by the FDA?
Sysmex Automated Coagulation Analyzer, Model CA-1500 (K010494) received a 510(k) decision of Substantially Equivalent on May 1, 2001, 70 days after the submission was received.
What is the product code of K010494?
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.