Ci-Trol Coagulation Controls II & III
FDA 510(k) K771346 · Dade, Baxter Travenol Diagnostics, Inc.
510(k) numberK771346
Submission
- Device name
- Ci-Trol Coagulation Controls II & III
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
Mchenry, IL, US - Received
- July 20, 1977
- Decision date
- August 22, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Ci-Trol Coagulation Controls II & III cleared by the FDA?
Ci-Trol Coagulation Controls II & III (K771346) received a 510(k) decision of Substantially Equivalent on August 22, 1977, 33 days after the submission was received.
What is the product code of K771346?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.