Submission Details
| 510(k) Number | K120900 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 26, 2012 |
| Decision Date | May 31, 2013 |
| Days to Decision | 431 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
Cleared
Traditional
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
May 2013
Decision
431d
Days
Class 2
Risk
About This 510(k) Submission
K120900 is an FDA 510(k) clearance for the I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2, a Plasma, Coagulation Control (Class II — Special Controls, product code GGN), submitted by Cliniqa Corporation (San Marcos, US). The FDA issued a Cleared decision on May 31, 2013, 431 days after receiving the submission on March 26, 2012. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.
Device Classification
| Product Code | GGN — Plasma, Coagulation Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.5425 |
Manufacturer
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