Behring Coagulation Timer Analyzer (BCT)
FDA 510(k) K001064 · Dade Behring, Inc.
510(k) numberK001064
Submission
- Device name
- Behring Coagulation Timer Analyzer (BCT)
- Applicant
- Dade Behring, Inc.
P.O. Box 6101, Newark, DE, US - Received
- April 3, 2000
- Decision date
- June 21, 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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Questions and answers
When was Behring Coagulation Timer Analyzer (BCT) cleared by the FDA?
Behring Coagulation Timer Analyzer (BCT) (K001064) received a 510(k) decision of Substantially Equivalent on June 21, 2000, 79 days after the submission was received.
What is the product code of K001064?
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.