Cascade Liquid Coagulation Control Levels 1, 2, and 3
FDA 510(k) K992829 · Medical Analysis Systems, Inc.
510(k) numberK992829
Submission
- Device name
- Cascade Liquid Coagulation Control Levels 1, 2, and 3
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- August 23, 1999
- Decision date
- November 22, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Cascade Liquid Coagulation Control Levels 1, 2, and 3 cleared by the FDA?
Cascade Liquid Coagulation Control Levels 1, 2, and 3 (K992829) received a 510(k) decision of Substantially Equivalent on November 22, 1999, 91 days after the submission was received.
What is the product code of K992829?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.