I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02
FDA 510(k) K071319 · Bio-Rad, Diagnostics Grp.
510(k) numberK071319
Submission
- Device name
- I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02
- Applicant
- Bio-Rad, Diagnostics Grp.
Irvine, CA, US - Received
- May 10, 2007
- Decision date
- June 26, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02 cleared by the FDA?
I-Stat Activated Clotting Time (Act) Control Set Level 1 and Level 2, Models 07G82-01, 07G82-02 (K071319) received a 510(k) decision of Substantially Equivalent on June 26, 2007, 47 days after the submission was received.
What is the product code of K071319?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.