I-Stat PT Control Leviel 1 I-Stat PT Control Level 2
FDA 510(k) K120900 · Cliniqa Corporation
510(k) numberK120900
Submission
- Device name
- I-Stat PT Control Leviel 1 I-Stat PT Control Level 2
- Applicant
- Cliniqa Corporation
San Marcos, CA, US - Received
- March 26, 2012
- Decision date
- May 31, 2013
- 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 I-Stat PT Control Leviel 1 I-Stat PT Control Level 2 cleared by the FDA?
I-Stat PT Control Leviel 1 I-Stat PT Control Level 2 (K120900) received a 510(k) decision of Substantially Equivalent on May 31, 2013, 431 days after the submission was received.
What is the product code of K120900?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.