The following data is part of a premarket notification filed by Cliniqa Corporation with the FDA for I-stat Pt Control Leviel 1 I-stat Pt Control Level 2.
| Device ID | K120900 |
| 510k Number | K120900 |
| Device Name: | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 |
| Classification | Plasma, Coagulation Control |
| Applicant | CLINIQA CORPORATION 288 DISTRIBUTION STREET San Marcos, CA 92078 |
| Contact | Dawn Gast |
| Correspondent | Dawn Gast CLINIQA CORPORATION 288 DISTRIBUTION STREET San Marcos, CA 92078 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-26 |
| Decision Date | 2013-05-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00054749001248 | K120900 | 000 |
| 00054749001231 | K120900 | 000 |
| 00054749001224 | K120900 | 000 |
| 00054749001217 | K120900 | 000 |