Cobe Angel Whole Blood Separation System
FDA 510(k) K042473 · Cobe Cardiovascular, Inc.
510(k) numberK042473
Submission
- Device name
- Cobe Angel Whole Blood Separation System
- Applicant
- Cobe Cardiovascular, Inc.
Arvada, CO, US - Received
- September 13, 2004
- Decision date
- November 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
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Questions and answers
When was Cobe Angel Whole Blood Separation System cleared by the FDA?
Cobe Angel Whole Blood Separation System (K042473) received a 510(k) decision of Substantially Equivalent on November 19, 2004, 67 days after the submission was received.
What is the product code of K042473?
The FDA product code is JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.